MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD DC BEAD; HCG/KRD SINGLE USE IMPLANTABLE MEDICAL DEVICE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems High Blood Pressure/ Hypertension (1908); Toxicity (2333); Ascites (2596)

Event Type  Injury  

Manufacturer Narrative

Dc bead with irinotecan was reported to have been used in the treatment of these patients.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.

Event Description

Rapid disease progression.Grade 2-3 toxicities (cholecystitis, pancreatitis or non-malignant ascites).Grade 3/4 arterial hypertension crises.Grade 3 post-embolization syndrome.Grade 2-3 toxicities (cholecystitis, pancreatitis or non-malignant ascites).Grade 2-3 toxicities (cholecystitis, pancreatitis or non-malignant ascites).Limiting toxicity.Case description: initial information received on 16-jan-2017: this literature device report was published in the annals of oncology by pointet et al., entitled "dc-beads loaded with irinotecan combined with systemic chemotherapy for pretreated liver dominant metastatic colorectal cancer: procedure and outcomes of 49 patients", concerning 49 patients (mean age: 63 years) of unknown gender.The patients' medical history included pretreated liver dominant metastatic colorectal cancer (mcrc).Additionally, all patients had previously received chemotherapy by folfox (leucovorin calcium, fluorouracil and oxaliplatin) and folfiri (leucovorin calcium, fluorouracil and irinotecan) and 49% with biotherapies.The co-suspect medication for patients receiving debiri included systemic chemotherapy (capecitabine: 26%, folfox +/- bevacizumab: 51%, other: 23%).On an unspecified date, between apr-2011 and apr-2014, all consecutive ecogps 0-2 patients, with stable or progressive liver-dominant mcrc pretreated at least 2 previous chemotherapy lines, underwent 81 debiri (dc-beads loaded with irinotecan) sessions administered in a lobar manner in the same session.The dc bead lot numbers, expiration date, bead size and loaded volume of irinotecan were not reported.On an unspecified date, 35% of the patients did not receive the second dose debiri due to a rapid disease progression (20%) or limiting toxicity (15%).On an unspecified date, altogether, 45 (55%) grade 3/4 arterial hypertension crisis occurred during the procedure, 11 (14%) grade 3 post-embolization syndrome and 5 (6%) grade 2-3 toxicities (cholecystitis, pancreatitis or non-malignant ascites) were observed.All toxicities were successfully managed.No toxic death occurred.The mean hospital stay was 4.5 days.The outcome of the events rapid disease progression, arterial hypertension crisis and post-embolization syndrome was not reported.The reporting author did not provide an assessment of the seriousness of the events.However, the reporter considered that debri plus systemic chemotherapy for pretreated liver dominant metastatic colorectal cancer provided promising efficacy results together with specific and severe side effects that need to be adequately managed.The company considered the events rapid disease progression, arterial hypertension crisis, post-embolization syndrome, grade 2-3 toxicities (cholecystitis, pancreatitis or non-malignant ascites) as serious (medically significant), and the event limiting toxicity as non-serious.Follow-up information will be requested.Case comment: hypertensive crisis, post embolization syndrome, cholecystitis and pancreatitis are considered listed according to dc bead current reference safety information whereas disease progression, ascites and chemotherapy toxicity attenuation are unlisted.In agreement with the assessment made by the reporter, the company considered the events hypertensive crisis, post embolization syndrome, cholecystitis, pancreatitis and ascites related to the use of dc bead.Of note, hypertensive crisis, post embolization syndrome, cholecystitis, pancreatitis are known complications of the embolization procedure.Furthermore, the concomitant use of systemic chemotherapy may also be a reasonable explanation.In absence of an assessment made by the reporter, the company considered the events disease progression and chemotherapy toxicity attenuation not related to the use of dc bead and rather related to underlying 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.

Manufacturer Narrative

Dc bead with irinotecan was reported to have been used in the treatment of these patients.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.

Event Description

Rapid disease progression [disease progression].Grade 2-3 toxicities (cholecystitis, pancreatitis or non-malignant ascites) [ascites].Grade 3/4 arterial hypertension crises [hypertensive crisis].Grade 3 post-embolization syndrome [post embolisation syndrome].Grade 2-3 toxicities (cholecystitis, pancreatitis or non-malignant ascites) [cholecystitis].Grade 2-3 toxicities (cholecystitis, pancreatitis or non-malignant ascites) [pancreatitis].Limiting toxicity [chemotherapy toxicity attenuation].Case description: initial information received on 16-jan-2017: this literature device report was published in the annals of oncology by pointet et al., entitled "dc-beads loaded with irinotecan combined with systemic chemotherapy for pretreated liver dominant metastatic colorectal cancer: procedure and outcomes of 49 patients", concerning 49 patients (mean age: 63 years) of unknown gender.The patients' medical history included pretreated liver dominant metastatic colorectal cancer (mcrc).Additionally, all patients had previously received chemotherapy by folfox (leucovorin calcium, fluorouracil and oxaliplatin) and folfiri (leucovorin calcium, fluorouracil and irinotecan) and 49% with biotherapies.The co-suspect medication for patients receiving debiri included systemic chemotherapy (capecitabine: 26%, folfox +/- bevacizumab: 51%, other: 23%).On an unspecified date, between apr-2011 and apr-2014, all consecutive ecogps 0-2 patients, with stable or progressive liver-dominant mcrc pretreated at least 2 previous chemotherapy lines, underwent 81 debiri (dc-beads loaded with irinotecan) sessions administered in a lobar manner in the same session.The dc bead lot numbers, expiration date, bead size and loaded volume of irinotecan were not reported.On an unspecified date, 35% of the patients did not receive the second dose debiri due to a rapid disease progression (20%) or limiting toxicity (15%).On an unspecified date, altogether, 45 (55%) grade 3/4 arterial hypertension crisis occurred during the procedure, 11 (14%) grade 3 post-embolization syndrome and 5 (6%) grade 2-3 toxicities (cholecystitis, pancreatitis or non-malignant ascites) were observed.All toxicities were successfully managed.No toxic death occurred.The mean hospital stay was 4.5 days.The outcome of the events rapid disease progression, arterial hypertension crisis and post-embolization syndrome was not reported.The reporting author did not provide an assessment of the seriousness of the events.However, the reporter considered that debri plus systemic chemotherapy for pretreated liver dominant metastatic colorectal cancer provided promising efficacy results together with specific and severe side effects that need to be adequately managed.The company considered the events rapid disease progression, arterial hypertension crisis, post-embolization syndrome, grade 2-3 toxicities (cholecystitis, pancreatitis or non-malignant ascites) as serious (medically significant), and the event limiting toxicity as non-serious.Follow-up information will be requested.Additional information on 16-feb-2017: follow-up information has been sought.As of 16-feb-2017, no additional information was received.Case comment: hypertensive crisis, post embolization syndrome, cholecystitis and pancreatitis are considered listed according to dc bead current reference safety information whereas disease progression, ascites and chemotherapy toxicity attenuation are unlisted.In agreement with the assessment made by the reporter, the company considered the events hypertensive crisis, post embolization syndrome, cholecystitis, pancreatitis and ascites related to the use of dc bead.Of note, hypertensive crisis, post embolization syndrome, cholecystitis, pancreatitis are known complications of the embolization procedure.Furthermore, the concomitant use of systemic chemotherapy may also be a reasonable explanation.In absence of an assessment made by the reporter, the company considered the events disease progression and chemotherapy toxicity attenuation not related to the use of dc bead and rather related to underlying 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.

Manufacturer Narrative

Dc bead with irinotecan was reported to have been used in the treatment of these patients.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.

Event Description

Rapid disease progression, grade 2-3 toxicities (cholecystitis, pancreatitis or non-malignant ascites) [ascites], grade 3/4 arterial hypertension crises, grade 3 post-embolization syndrome, grade 2-3 toxicities (cholecystitis, pancreatitis or non-malignant ascites) [cholecystitis], grade 2-3 toxicities (cholecystitis, pancreatitis or non-malignant ascites) [pancreatitis], limiting toxicity [chemotherapy toxicity attenuation].Case description: initial information received on 16-jan-2017: this literature device report was published in the annals of oncology by pointet et al., entitled "dc-beads loaded with irinotecan combined with systemic chemotherapy for pretreated liver dominant metastatic colorectal cancer: procedure and outcomes of 49 patients", concerning 49 patients (mean age: 63 years) of unknown gender.The patients' medical history included pretreated liver dominant metastatic colorectal cancer (mcrc).Additionally, all patients had previously received chemotherapy by folfox (leucovorin calcium, fluorouracil and oxaliplatin) and folfiri (leucovorin calcium, fluorouracil and irinotecan) and 49% with biotherapies.The co-suspect medication for patients receiving debiri included systemic chemotherapy (capecitabine: 26%, folfox +/- bevacizumab: 51%, other: 23%).On an unspecified date, between apr-2011 and apr-2014, all consecutive ecogps 0-2 patients, with stable or progressive liver-dominant mcrc pretreated at least 2 previous chemotherapy lines, underwent 81 debiri (dc-beads loaded with irinotecan) sessions administered in a lobar manner in the same session.The dc bead lot numbers, expiration date, bead size and loaded volume of irinotecan were not reported.On an unspecified date, 35% of the patients did not receive the second dose debiri due to a rapid disease progression (20%) or limiting toxicity (15%).On an unspecified date, altogether, 45 (55%) grade 3/4 arterial hypertension crisis occurred during the procedure, 11 (14%) grade 3 post-embolization syndrome and 5 (6%) grade 2-3 toxicities (cholecystitis, pancreatitis or non-malignant ascites) were observed.All toxicities were successfully managed.No toxic death occurred.The mean hospital stay was 4.5 days.The outcome of the events rapid disease progression, arterial hypertension crisis and post-embolization syndrome was not reported.The reporting author did not provide an assessment of the seriousness of the events.However, the reporter considered that debri plus systemic chemotherapy for pretreated liver dominant metastatic colorectal cancer provided promising efficacy results together with specific and severe side effects that need to be adequately managed.The company considered the events rapid disease progression, arterial hypertension crisis, post-embolization syndrome, grade 2-3 toxicities (cholecystitis, pancreatitis or non-malignant ascites) as serious (medically significant), and the event limiting toxicity as non-serious.Follow-up information will be requested.Additional information on 16-feb-2017: follow-up information has been sought.As of 16-feb-2017, no additional information was received.Final assessment on 15-mar-2017: follow up information has been sought to further investigate the event but no new information has been received.After three follow up attempts, the case is considered lost to follow up.No device failure has been identified as a result of this adverse event.It has been assessed that no corrective action is necessary at this time and the report is considered final.Case comment: hypertensive crisis, post embolization syndrome, cholecystitis and pancreatitis are considered listed according to dc bead current reference safety information whereas disease progression, ascites and chemotherapy toxicity attenuation are unlisted.In agreement with the assessment made by the reporter, the company considered the events hypertensive crisis, post embolization syndrome, cholecystitis, pancreatitis and ascites related to the use of dc bead.Of note, hypertensive crisis, post embolization syndrome, cholecystitis, pancreatitis are known complications of the embolization procedure.Furthermore, the concomitant use of systemic chemotherapy may also be a reasonable explanation.In absence of an assessment made by the reporter, the company considered the events disease progression and chemotherapy toxicity attenuation not related to the use of dc bead and rather related to underlying 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.

• Brand Name: DC BEAD
• Type of Device: HCG/KRD SINGLE USE IMPLANTABLE MEDICAL DEVICE
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; farnham, surrey ; UK
• Manufacturer (Section G): BIOCOMPATIBLES UK LTD; farnham business park; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: farnham business park; weydon lane; farnham, surrey GU9 8-QL ; 1252 732 7
• MDR Report Key: 6279217
• MDR Text Key: 65830216
• Report Number: 3002124545-2017-00002
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K094018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other