| Model Number 100-300 MICROM |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Edema (1820); Heart Failure (2206); Therapeutic Response, Decreased (2271); Vascular System (Circulation), Impaired (2572)
|
| Event Date 02/01/2011 |
|
Event Type
Death
|
|
Manufacturer Narrative
|
|
Dc bead with doxorubicin was reported to have been used in the treatment of this patient.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.The device has not been sent to the manufacturer for eval.No batch review was possible for this case as the lot number could not be ascertained.No product malfunction/deficiency has been identified.Literature description: journal: cardiovascular and interventional radiology.Author: pitton mb, kloeckner r, ruckes c, wirth gm, eichhorn w, worns ma, weinmann a, schreckenberger m, galle pr, otto g, dueber c.Title: randomized comparison of selective internal radiotherapy (sirt) versus drug-eluting bead transarterial chemoembolization (deb-tace) for the treatment of hepatocellular carcinoma.Volume: 38.Year: 2015.Pages: 353-360.
|
| |
|
Event Description
|
|
Arteriovenous shunt [arteriovenous malformation].Progressive heart failure [cardiac failure].Edema [oedema].Substantial tumor progression [neoplasm progression].Case description: initial information rec'd on 30-jun-2015: this literature medical device report was published in 2015 in the journal cardiovascular and interventional radiology by pitton et al.With the title "randomized comparison of selective internal radiotherapy (sirt) versus drug-eluting bead transarterial chemoembolization (deb-tace) for the treatment of hepatocellular carcinoma", concerning a female patient of unspecified age affected by hepatocellular carcinoma.Patient's medical history and concomitant medications were not reported.The patient was part of a randomized trial on 24 patients comparing selective interval radiotherapy (sirt) versus drug-eluting bead transarterial (deb-tace) for treating hcc.Tace was repeated every 6 weeks until no more viable tumor was detected by mri.The patients were stratified according to tumor load (less than 25% / more than 25%).All patients suffered from m0 n0 hcc.Liver mri was performed in all patients to obtain a final diagnosis.To rule out extrahepatic tumor spread, all patients underwent ct of the thorax and abdomen.On an unspecified date, the patient underwent tace and dc bead 100-300 microm (batch number and expiration date not reported) loaded with doxorubicin for treatment of hcc.Three months after tace procedure, the patient experienced progressive heart failure and edema.She did not receive repeated tace because of an arteriovenous shunt and substantial tumor progression after the one session.No other information was provided.The authors did not assess the relationship between dc bead and the progressive heart failure, edema, arteriovenous malformation and neoplasm progression presented by the patient.Case comment: arteriovenous malfunction, progressive heart failure, edema, and neoplasm progression are considered unlisted according to the current instruction for use of dc bead.The company considers the events progressive heart failure, and edema as not related to dc bead due to the time-lapse between the procedure and the occurrence of the events.Arteriovenous malformation could be possible related to dc bead, since based on its mode of action, its role cannot be ruled out.Neoplasm progression is considered not related to dc bead but most likely related to the course of the disease.This single case report does not modify the risk benefit balance of dc bead.The company is continuously monitoring all respective reports received, and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.The first sales for dc bead in (b)(6) were in 2004.(b)(4).
|
| |
|
Manufacturer Narrative
|
|
Dc bead with doxorubicin was reported to have been used in the treatment of this patient.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.The device has not been sent to the manufacturer for evaluation.No batch review was possible for this case as the lot number could not be ascertained.No product malfunction/deficiency has been identified.
|
| |
|
Event Description
|
|
Progressive heart failure.Progressive liver failure.Case description: initial information received on 30-jun-2015: this literature medical device report was published in 2015 in the journal cardiovascular and interventional radiology by pitton et al.With the title "randomized comparison of selective internal radiotherapy (sirt) versus drug-eluting bead transarterial chemoembolization (deb-tace) for the treatment of hepatocellular carcinoma", concerning a female patient of unspecified age affected by hepatocellular carcinoma (hcc).Patient's medical history and concomitant medications were not reported.The patient was part of a randomized trial on 24 patients comparing selective internal radiotherapy (sirt) versus drug-eluting bead transarterial (deb-tace) for treating hcc.Tace was repeated every 6 weeks until no more viable tumor was detected by mri.The patients were stratified according to tumor load (less than 25% / more than 25%).All patients suffered from m0 n0 hcc.Liver mri was performed in all patients to obtain a final diagnosis.To rule out extrahepatic tumor spread, all patients underwent ct of the thorax and abdomen.On an unspecified date, the patient underwent tace with dc bead 100-300 microm (batch number and expiration date not reported) loaded with doxorubicin for treatment of hcc.Three months after tace procedure, the patient experienced progressive heart failure and edema.She did not receive repeated tace because of an arteriovenous shunt and substantial tumor progression after the one session.No other information was provided.The authors did not assess the relationship between dc bead and the progressive heart failure, edema, arteriovenous malformation and neoplasm progression presented by the patient.Follow-up information received on 23-jul-2015: (b)(6) (b)(4) was provided.Dc bead is a class iib device.Sales data, number of similar incidents, assessment of frequency rate and information on dc bead distributor were provided in case comments.After internal revision, the coding and case assessment have been changed with arteriovenous malformation now considered as being not related to treatment and progressive heart failure as being related to treatment.Case comments below have been changed accordingly.Follow-up information received on 04-sep-2015: follow-up information was received from a different physician.Patient's details (initials, gender and date of birth) were reported.The female elderly patient developed hcc because of hcv liver cirrhosis.She underwent dc bead-tace on (b)(6) 2011 (product lot number not available).According to the reporter, on an unspecified date, the patient experienced progressive heart, liver failure and deceased (cause of death and whether an autopsy was performed were not reported) the physician stated that it was unclear if the progressive heart failure and edema experienced by the patient were related to dc bead, and he did not assess the relationship between dc bead and the liver failure.Case comment: arteriovenous malformation, progressive heart failure, edema, neoplasm progression and liver failure are considered unlisted according to the current instruction for use of dc bead.The company considers the event progressive heart failure as related to the treatment, since the patient's worsening condition could be due to epirubicin getting through to the systemic circulation in higher than desired amounts due to the arteriovenous malformation.Although unlikely, the worsening heart failure relatedness to the treatment remains therefore medically possible.Arteriovenous malformation is considered not related to the treatment, since it must be present from birth or due to tumor.Edema is considered not related to dc bead as well due to the timelapse between the procedure and the occurrence of the event.Neoplasm progression is considered not related to dc bead but most likely related to the course of the disease.Based on the very limited available information, it is unknown if the liver failure occurred during or immediately following the procedure.Since a causal relationship between the event and the procedure cannot be excluded, the company considers the event liver failure experienced by the patient as related, as dc bead role cannot be excluded.This single case report does not modify the risk benefit balance of dc bead.The company is continuously monitoring all respective reports received, and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis (b)(4).The number of similar incidents were reported as : - case (b)(4): reported on 14-mar-2014; country: (b)(6); events: bigeminy, hypertension; outcome: bigeminy resolved, hypertension ongoing.- case (b)(4): reported on 24-aug-2014; country: (b)(6); event: vagal reaction; outcome: resolved.- case (b)(4): reported on 01-mar-2015; country: (b)(6); event: cardiac arrest as a result of sepsis; outcome: fatal.- case (b)(4): reported on 06-jul-2015; country: germany; event: cardiac disorder; outcome: fatal.The estimated number of patient treatments is estimated to be 58,426 (reporting rate of 0.009%) in the eu and 29,960 (reporting rate of 0.002%) in the row (no differentiation between european countries available).No batch number was provided therefore batch review was not possible for this case.Dc bead is sold in (b)(6) via the manufacturer biocompatibles (part of btg).There is no distributor or european representative.After reception of follow-up information on 23-jul-2015, the case comments were changed.After reception of follow-up information on 04-sep-2015, the case comments were changed.
|
| |
|
Manufacturer Narrative
|
|
Dc bead with doxorubicin was reported to have been used in the treatment of this patient.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.The device has not been sent to the manufacturer for evaluation.No batch review was possible for this case as the lot number could not be ascertained.No product malfunction/deficiency has been identified.
|
| |
|
Event Description
|
|
Progressive liver failure [hepatic failure] progressive heart failure [cardiac failure] arteriovenous shunt [arteriovenous malformation] edema [oedema] substantial tumor progression [neoplasm progression] case description: initial information received on 30-jun-2015: this literature medical device report was published in 2015 in the journal cardiovascular and interventional radiology by pitton et al.With the title "randomized comparison of selective internal radiotherapy (sirt) versus drug-eluting bead transarterial chemoembolization (deb-tace) for the treatment of hepatocellular carcinoma", concerning a female patient of unspecified age affected by hepatocellular carcinoma (hcc).Patient's medical history and concomitant medications were not reported.The patient was part of a randomized trial on 24 patients comparing selective internal radiotherapy (sirt) versus drug-eluting bead transarterial (deb-tace) for treating hcc.Tace was repeated every 6 weeks until no more viable tumor was detected by mri.The patients were stratified according to tumor load (less than 25% / more than 25%).All patients suffered from m0 n0 hcc.Liver mri was performed in all patients to obtain a final diagnosis.To rule out extrahepatic tumor spread, all patients underwent ct of the thorax and abdomen.On an unspecified date, the patient underwent tace with dc bead 100-300 microm (batch number and expiration date not reported) loaded with doxorubicin for treatment of hcc.Three months after tace procedure, the patient experienced progressive heart failure and edema.She did not receive repeated tace because of an arteriovenous shunt and substantial tumor progression after the one session.No other information was provided.The authors did not assess the relationship between dc bead and the progressive heart failure, edema, arteriovenous malformation and neoplasm progression presented by the patient.Follow-up information received on 23-jul-2015: bfarm reference number (b)(4) was provided.Dc bead is a class iib device.Sales data, number of similar incidents, assessment of frequency rate and information on dc bead distributor were provided in case comments.After internal revision, the coding and case assessment have been changed with arteriovenous malformation now considered as being not related to treatment and progressive heart failure as being related to treatment.Case comments below have been changed accordingly.Follow-up information received on 04-sep-2015: follow-up information was received from a different physician.Patient's details (initials, gender and date of birth) were reported.The female elderly patient developed (b)(6) because of (b)(6) liver cirrhosis.She underwent dc bead-tace on (b)(6) 2011 (product lot number not available).According to the reporter, on an unspecified date, the patient experienced progressive heart, liver failure and deceased (cause of death and whether an autopsy was performed were not reported) the physician stated that it was unclear if the progressive heart failure and edema experienced by the patient were related to dc bead, and he did not assess the relationship between dc bead and the liver failure.Follow up information received on 06-oct-2015: patient's passed away on (b)(6) 2011 and the cause of death was reported as liver failure.Onset date of liver failure and heart failure was reported as (b)(6) 2011.The reporting physician considered the event heart failure not related to dc bead and the event liver failure as probably related to dc bead.Case comment: arteriovenous malformation, progressive heart failure, edema, neoplasm progression and liver failure are considered unlisted according to the current instruction for use of dc bead.The company considers the event progressive heart failure as related to the treatment, since the patient's worsening condition could be due to epirubicin getting through to the systemic circulation in higher than desired amounts due to the arteriovenous malformation.Although unlikely, the worsening heart failure relatedness to the treatment remains therefore medically possible.Arteriovenous malformation is considered not related to the treatment, since it must be present from birth or due to tumor.Edema is considered not related to dc bead as well due to the timelapse between the procedure and the occurrence of the event.Neoplasm progression is considered not related to dc bead but most likely related to the course of the disease.The physician assessed the event liver failure as probably related to dc bead, based on the company considers the event liver failure experienced by the patient as related to dc bead.This single case report does not modify the risk benefit balance of dc bead.The company is continuously monitoring all respective reports received, and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis the first sales for dc bead in the (b)(6) were in 2004.Sales data from jan-2010 for dc bead is: eu 116.851 vials and row 59.919 vials.No differentiation between european countries was available.The number of similar incidents were reported as : - case (b)(6): reported on (b)(6) 2014; country: (b)(6); events: bigeminy, hypertension; outcome: bigeminy resolved, hypertension ongoing - case (b)(6): reported on (b)(6) 2014; country: (b)(6); event: vagal reaction; outcome: resolved - case (b)(6): reported on (b)(6) 2015; country: france; event: cardiac arrest as a result of sepsis; outcome: fatal - (b)(6): reported on (b)(6) 2015; country: (b)(6); event: cardiac disorder; outcome: fatal the estimated number of patient treatments is estimated to be (b)(4) in the eu and (b)(4) in the row (no differentiation between european countries available).No batch number was provided therefore batch review was not possible for this case.Dc bead is sold in (b)(6) via the manufacturer biocompatibles (part of btg).There is no distributor or european representative.After reception of follow-up information on 23-jul-2015, the case comments were changed.After reception of follow-up information on 04-sep-2015, the case comments were changed.After reception of the follow up information received on 06-oct-2015 the event liver failure was assessed as probably related to dc bead procedure; the event heart failure was reported by the physician as not related to dc bead.Despite the reporter assessment the company physician believes the events of heart failure and edema are possibly related to dc bead since a relationship cannot be excluded.
|
| |
|
Manufacturer Narrative
|
|
Follow-up information received on (b)(6) 2015.(b)(6) reference number (b)(4) was provided.(b)(6) is a class llb device.Sales data, number of similar incidents, assessment of frequency rate and information on dc bead distributor were provided in case comments.After internal revision, the coding and case assessment have been changed with arteriovenous malformation now considered as being not related to treatment and progressive heart failure as being related to treatment.Case comments below have been changed accordingly.Case comment: arteriovenous malformation, progressive heart failure, edema and neoplasm progression are considered unlisted according to the current instruction for use of dc bead.The company considers the event progressive heart failure as related to the treatment, since the patient's worsening condition could be due to epirubicin getting through to the systemic circulation in higher than desired amounts due to the arteriovenous malformation although unlikely, the worsening heart failure relatedness to the treatment remains therefore medically possible.Arteriovenous malformation is considered not related to the treatment, since it must be present from birth or due to tumor.(b)(6) is considered not related to dc bead as well due to the timelapse between the procedure and the occurrence of the event.Neoplasm progression is considered not related to dc bead but most likely related to the course of the disease.This single case report does not modify the risk benefit balance of dc bead.The company is continuously monitoring all respective reports received, and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis the first sales for dc bead in the (b)(6) were in 2004.Sales data from (b)(6) 2010 for dc bead is: (b)(4) vials and row (b)(4) vials.No differentiation between (b)(6) countries was available.The number of similar incidents were reported as: case (b)(4): reported on (b)(4) 2014, country: (b)(4); events.Bigeminy, hypertension; outcome: bigeminy resolved, hypertension ongoing.Case (b)(4) reported on (b)(4), 2014; country: (b)(6); event: vagal reaction; outcome: resolved.Case (b)(4): reported on (b)(4) 2015; country: (b)(6), event: cardiac arrest as a result of sepsis, outcome.Fatal.Case (b)(4): reported on j(b)(6) 2015; country (b)(6); event: cardiac disorder; outcome: fatal.The estimated number of patient treatments is estimated to be (b)(4) (reporting rate of (b)(4) in the (b)(4) and (b)(4)(reporting rate of (b)(4)%) in the row (no differentiation between (b)(4) countries available).No batch number was provided therefore batch review was not possible for this case.Dc bead is sold in (b)(4) via the manufacturer biocompatibles (part of btg).There is no distributor or (b)(4) representative.Additional information is being sought and will be reported as a follow up report.After reception of follow-up information on (b)(4) 2015, the case comments were changed.
|
| |
|
Manufacturer Narrative
|
|
Dc bead with doxorubicin was reported to have been used in the treatment of this patient.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.The device has not been sent to the manufacturer for evaluation.No batch review was possible for this case as the lot number could not be ascertained.No product malfunction/deficiency has been identified.
|
| |
|
Event Description
|
|
Progressive liver failure [hepatic failure] progressive heart failure [cardiac failure] arteriovenous shunt [arteriovenous malformation] edema [oedema] substantial tumor progression [neoplasm progression] case description: initial information received on (b)(6) 2015.This literature medical device report was published in 2015 in the journal cardiovascular and interventional radiology by (b)(6).With the title "randomized comparison of selective internal radiotherapy (sirt) versus drug-eluting bead transarterial chemoembolization (deb-tace) for the treatment of hepatocellular carcinoma", concerning a female patient of unspecified age affected by hepatocellular carcinoma (hcc).Patient's medical history and concomitant medications were not reported.The patient was part of a randomized trial on (b)(6) patients comparing selective internal radiotherapy (sirt) versus drug-eluting bead transarterial (deb-tace) for treating hcc.Tace was repeated every 6 weeks until no more viable tumor was detected by mri.The patients were stratified according to tumor load (less than (b)(6)% / more than (b)(6)%).All patients suffered from (b)(6).Liver mri was performed in all patients to obtain a final diagnosis.To rule out extrahepatic tumor spread, all patients underwent ct of the thorax and abdomen.On an unspecified date, the patient underwent tace with dc bead (b)(4) (batch number and expiration date not reported) loaded with doxorubicin for treatment of hcc.Three months after tace procedure, the patient experienced progressive heart failure and edema.She did not receive repeated tace because of an arteriovenous shunt and substantial tumor progression after the one session.No other information was provided.The authors did not assess the relationship between dc bead and the progressive heart failure, edema, arteriovenous malformation and neoplasm progression presented by the patient.Follow-up information received on 23-jul-2015: bfarm reference number (b)(4) was provided.Dc bead is a class iib device.Sales data, number of similar incidents, assessment of frequency rate and information on dc bead distributor were provided in case comments.After internal revision, the coding and case assessment have been changed with arteriovenous malformation now considered as being not related to treatment and progressive heart failure as being related to treatment.Case comments below have been changed accordingly.Follow-up information received on 04-sep-2015.Follow-up information was received from a different physician.Patient's details (initials, gender and date of birth) were reported.The female elderly patient developed hcc because of hcv liver cirrhosis.She underwent dc bead-tace on (b)(6) 2011 (product lot number not available).According to the reporter, on an unspecified date, the patient experienced progressive heart, liver failure and deceased (cause of death and whether an autopsy was performed were not reported).The physician stated that it was unclear if the progressive heart failure and edema experienced by the patient were related to dc bead, and he did not assess the relationship between dc bead and the liver failure.Follow up information received on 06-oct-2015.Patient's passed away on (b)(6) 2011 and the cause of death was reported as liver failure.Onset date of liver failure and heart failure was reported as (b)(6) 2011.The reporting physician considered the event heart failure not related to dc bead and the event liver failure as probably related to dc bead.Case comment: arteriovenous malformation, progressive heart failure, edema, neoplasm progression and liver failure are considered unlisted according to the current instruction for use of dc bead.The company considers the event progressive heart failure as related to the treatment, since the patient's worsening condition could be due to epirubicin getting through to the systemic circulation in higher than desired amounts due to the arteriovenous malformation.Although unlikely, the worsening heart failure relatedness to the treatment remains therefore medically possible.Arteriovenous malformation is considered not related to the treatment, since it must be present from birth or due to tumor.Edema is considered not related to dc bead as well due to the timelapse between the procedure and the occurrence of the event.Neoplasm progression is considered not related to dc bead but most likely related to the course of the disease.The physician assessed the event liver failure as probably related to dc bead, based on the company considers the event liver failure experienced by the patient as related to dc bead.This single case report does not modify the risk benefit balance of dc bead.The company is continuously monitoring all respective reports received, and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis the first sales for dc bead in the (b)(4) were in 2004.Sales data from (b)(4) 2010 for dc bead is: (b)(4) vials and row (b)(4) vials.No differentciation between (b)(4) countries was available.The number of similar incidents were reported as : case (b)(4): reported on (b)(6) 2014; country: (b)(4); events: bigeminy, hypertension; outcome: bigeminy resolved, hypertension ongoing - case (b)(4): reported on (b)(6) 2014; country: (b)(4); event: vagal reaction; outcome: resolved - case (b)(4): reported on (b)(6) 2015; country: (b)(4); event: cardiac arrest as a result of sepsis; outcome: fatal - case (b)(4): reported on (b)(6) 2015; country: (b)(4); event: cardiac disorder; outcome: fatal.The estimated number of patient treatments is estimated to be (b)(6) (reporting rate of (b)(4)%) in the (b)(4) and (b)(4) reporting rate of (b)(4)%) in the row (no differenciation between (b)(4) countries available).No batch number was provided therefore batch review was not possible for this case.Dc bead is sold in (b)(4) via the manufacturer biocompatibles (part of btg).There is no distributor or (b)(4) representative.After reception of the follow up information received on 06-oct-2015 the event liver failure was assessed as probably related to dc bead procedure; the event heart failure was reported by the physician as not related to dc bead.Despite the reporter assessment the company physician believes the events of heart failure and edema are possibly related to dc bead since a relationship cannot be excluded.Final case assessment (b)(4) 2015: no device failure has been identified as a result of this adverse event.Follow up information was requested to further investigate the event.No new information is expected.It has been assessed that no corrective action is necessary at this time and the report is final.
|
| |
|
Search Alerts/Recalls
|
|
