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

Model Number 100-300 ¼M

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Pulmonary Embolism (1498); High Blood Pressure/ Hypertension (1908); Hypoxia (1918); Tricuspid Regurgitation (2112)

Event Type  Injury  

Event Description

Acute hypoxemic respiratory failure [respiratory failure]; post tace acute lung injury [acute lung injury]; worsened pulmonary hypertension [pulmonary hypertension]; mild right ventricular enlargement [dilatation ventricular]; worsened tricuspid regurgitation [tricuspid valve incompetence]; pulmonary embolism with doxorubicin eluting beads and or lipiodol [post procedural pulmonary embolism]; off-label use of lc bead as doxorubicin eluting [off label use of device].Case description: initial information received on 19-jan-2016: this spontaneous medical device report was received from a conference abstract entitled "an unexpected pulmonary complication following tace with low-dose doxorubicin-eluting beads and small-volume lipiodol for a small hcc" obtained from a literature review concerning a (b)(6), male patient.The patient's medical history included (b)(6) cirrhosis, a new and small recurrent hepatocellular carcinoma (hcc), portopulmonary hypertension, and tricuspid regurgitation.The patient previously underwent a doxorubicin-eluting bead transarterial chemoembolization (deb-tace) for a 3.9-cm right hepatic lobe hcc (without complication) and resulted in tumor size reduction.Concomitant medications were not provided.The patient received doxorubicin (40 mg/5ml)- eluting 100-300 micron lc beads as a second deb tace for a small recurrent hcc (lot number and expiration date unknown) on an unknown date "seven months" after the first deb-tace (lot number and expiration date unspecified).The co-suspect agent lipiodol, 1 ml (manufacturer and indication unspecified) followed the deb-tace.On an unspecified date, the patient developed post-tace acute lung injury (ali), acute hypoxemic respiratory failure following tace which may have resulted from pulmonary embolism with doxorubicin-eluting beads and/or lipiodol, mild right ventricular (rv) enlargement, and worsened pulmonary hypertension with worsened tricuspid regurgitation.Immediately after the second deb-tace procedure, the patient developed hypoxemia (spo2 88%).Chest computerized angiography (cta) was negative for pulmonary embolism, but showed multiple bilateral areas of ground-glass opacities.Transthoracic echocardiogram (tte) showed mild right ventricular (rv) enlargement, worsened pulmonary hypertension with worsened tricuspid regurgitation.Patient was transferred to the intensive care unit (icu) on hospital day 3 for worsening respiratory distress, and was treated empirically with broad-spectrum antibiotics initially.A work up for infectious causes of acute hypoxemic respiratory failure was negative.Solumedrol was initiated on hospital day 7 for post-tace acute lung injury (ali).Hypoxemia resolved two days later.The patient's respiratory function completely normalized, but he continues to have significant pulmonary hypertension requiring medical therapy.The outcome of pulmonary embolism, right ventricular enlargement, tricuspid regurgitation, and post-tace ali are unknown.The patient subsequently underwent a successful liver transplant.Of note, the use of doxorubicin with lc bead is considered to be off-label use of a device.The authors did not provide an assessment regarding the severity of the events but did indicate the relatedness of acute hypoxemic respiratory failure, post-tace ali, and post-procedural pulmonary embolism with lc bead, doxorubin and lipiodol as documented "the acute hypoxemic respiratory failure following tace in our patient may have resulted from pulmonary embolism with doxorubicin-eluting beads and/or lipiodol.The known risk factors for post-tace pulmonary complications (e.G.Large hypervascular hcc, av shunts, large-volume lipiodol, and trans-inferior phrenic artery embolization) were all absent in our patient, making the post-tace ali in our patient an unexpected event." the authors did not indicate the relatedness of right ventricular enlargement, worsened pulmonary hypertension or worsened tricuspid regurgitation with the use of lc bead.The company assessed all of the events as serious with criteria of prolonged hospitalization and medically significant.Company comment: the events of respiratory failure, acute lung injury, pulmonary hypertension, dilatation ventricular, and tricuspid valve incompetence are considered to be unlisted whereas post-procedural pulmonary embolism is listed according to lc bead current reference safety information.Off-label use of a device is unlisted.In agreement with the authors, the company considers respiratory failure, acute lung injury, and post-procedural pulmonary embolism as related to the use of lc bead and/or doxorubicin and lipiodol.In the absence of an assessment by the authors, the company considers pulmonary hypertension, dilatation ventricular, and tricuspid valve incompetence to be related to the use of lc bead until additional information can be obtained.The relatedness of off-label use of lc bead as doxorubicin-eluting is not assessable.This single case report does not modify the risk benefit balance of lc 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.

Event Description

Acute hypoxemic respiratory failure [respiratory failure].Post tace acute lung injury [acute lung injury].Worsened pulmonary hypertension [pulmonary hypertension].Mild right ventricular enlargement [dilatation ventricular].Worsened tricuspid regurgitation [tricuspid valve incompetence].Pulmonary embolism with doxorubicin eluting beads and or lipiodol [post procedural pulmonary embolism].Off-label use of lc bead as doxorubicin eluting [off label use of device].Case description: initial information received on 19-jan-2016: this spontaneous medical device report was received from a conference abstract entitled "an unexpected pulmonary complication following tace with low-dose doxorubicin-eluting beads and small-volume lipiodol for a small hcc" obtained from a literature review concerning a (b)(6) year old, male patient.The patient's medical history included (b)(6) cirrhosis, a new and small recurrent hepatocellular carcinoma (hcc), portopulmonary hypertension, and tricuspid regurgitation.The patient previously underwent a doxorubicin-eluting bead transarterial chemoembolization (deb-tace) for a 3.9-cm right hepatic lobe hcc (without complication) and resulted in tumor size reduction.Concomitant medications were not provided.The patient received doxorubicin (40 mg/5ml)- eluting 100-300 micron lc beads as a second deb tace for a small recurrent hcc (lot number and expiration date unknown) on an unknown date "seven months" after the first deb-tace (lot number and expiration date unspecified).The co-suspect agent lipiodol, 1 ml (manufacturer and indication unspecified) followed the deb-tace.On an unspecified date, the patient developed post-tace acute lung injury (ali), acute hypoxemic respiratory failure following tace which may have resulted from pulmonary embolism with doxorubicin-eluting beads and/or lipiodol, mild right ventricular (rv) enlargement, and worsened pulmonary hypertension with worsened tricuspid regurgitation.Immediately after the second deb-tace procedure, the patient developed hypoxemia (spo2 88%).Chest computerized angiography (cta) was negative for pulmonary embolism, but showed multiple bilateral areas of ground-glass opacities.Transthoracic echocardiogram (tte) showed mild right ventricular (rv) enlargement, worsened pulmonary hypertension with worsened tricuspid regurgitation.Patient was transferred to the intensive care unit (icu) on hospital day 3 for worsening respiratory distress, and was treated empirically with broad-spectrum antibiotics initially.A work up for infectious causes of acute hypoxemic respiratory failure was negative.Solumedrol was initiated on hospital day 7 for post-tace acute lung injury (ali).Hypoxemia resolved two days later.The patient's respiratory function completely normalized, but he continues to have significant pulmonary hypertension requiring medical therapy.The outcome of pulmonary embolism, right ventricular enlargement, tricuspid regurgitation, and post-tace ali are unknown.The patient subsequently underwent a successful liver transplant.Of note, the use of doxorubicin with lc bead is considered to be off-label use of a device.The authors did not provide an assessment regarding the severity of the events but did indicate the relatedness of acute hypoxemic respiratory failure, post-tace ali, and post-procedural pulmonary embolism with lc bead, doxorubin and lipiodol as documented "the acute hypoxemic respiratory failure following tace in our patient may have resulted from pulmonary embolism with doxorubicin-eluting beads and/or lipiodol.The known risk factors for post-tace pulmonary complications (e.G.Large hypervascular hcc, av shunts, large-volume lipiodol, and trans-inferior phrenic artery embolization) were all absent in our patient, making the post-tace ali in our patient an unexpected event." the authors did not indicate the relatedness of right ventricular enlargement, worsened pulmonary hypertension or worsened tricuspid regurgitation with the use of lc bead.The company assessed all of the events as serious with criteria of prolonged hospitalization and medically significant.Follow-up information has been sought.As of 24-feb-2016, no additional information has been received.The final report will be sent within 30 calendar days on 25-mar-2016.Follow-up information has been sought.As of 18-mar-2016, no additional information has been received.The final report will be sent within 30 calendar days on 22-apr-2016.Company comment: the events of respiratory failure, acute lung injury, pulmonary hypertension, dilatation ventricular, and tricuspid valve incompetence are considered to be unlisted whereas post-procedural pulmonary embolism is listed according to lc bead current reference safety information.Off-label use of a device is unlisted.In agreement with the authors, the company considers respiratory failure, acute lung injury, and post-procedural pulmonary embolism as related to the use of lc bead and/or doxorubicin and lipiodol.In the absence of an assessment by the authors, the company considers pulmonary hypertension, dilatation ventricular, and tricuspid valve incompetence to be related to the use of lc bead until additional information can be obtained.The relatedness of off-label use of lc bead as doxorubicin-eluting is not assessable.This single case report does not modify the risk benefit balance of lc 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.

Event Description

Acute hypoxemic respiratory failure [respiratory failure].Post tace acute lung injury [acute lung injury].Worsened pulmonary hypertension [pulmonary hypertension].Mild right ventricular enlargement [dilatation ventricular].Worsened tricuspid regurgitation [tricuspid valve incompetence].Pulmonary embolism with doxorubicin eluting beads and or lipiodol [post procedural pulmonary embolism].Off-label use of lc bead as doxorubicin eluting [off label use of device].Case description: initial information received on (b)(6)-2016: this spontaneous medical device report was received from a conference abstract entitled "an unexpected pulmonary complication following tace with low-dose doxorubicin-eluting beads and small-volume lipiodol for a small hcc" obtained from a literature review concerning a (b)(6) year old, male patient.The patient's medical history included (b)(6) cirrhosis, a new and small recurrent hepatocellular carcinoma (hcc), portopulmonary hypertension, and tricuspid regurgitation.The patient previously underwent a doxorubicin-eluting bead transarterial chemoembolization (deb-tace) for a 3.9-cm right hepatic lobe hcc (without complication) and resulted in tumor size reduction.Concomitant medications were not provided.The patient received doxorubicin (40 mg/5ml)- eluting 100-300 micron lc beads as a second deb tace for a small recurrent hcc (lot number and expiration date unknown) on an unknown date "seven months" after the first deb-tace (lot number and expiration date unspecified).The co-suspect agent lipiodol, 1 ml (manufacturer and indication unspecified) followed the deb-tace.On an unspecified date, the patient developed post-tace acute lung injury (ali), acute hypoxemic respiratory failure following tace which may have resulted from pulmonary embolism with doxorubicin-eluting beads and/or lipiodol, mild right ventricular (rv) enlargement, and worsened pulmonary hypertension with worsened tricuspid regurgitation.Immediately after the second deb-tace procedure, the patient developed hypoxemia (spo2 88%).Chest computerized angiography (cta) was negative for pulmonary embolism, but showed multiple bilateral areas of ground-glass opacities.Transthoracic echocardiogram (tte) showed mild right ventricular (rv) enlargement, worsened pulmonary hypertension with worsened tricuspid regurgitation.Patient was transferred to the intensive care unit (icu) on hospital day 3 for worsening respiratory distress, and was treated empirically with broad-spectrum antibiotics initially.A work up for infectious causes of acute hypoxemic respiratory failure was negative.Solumedrol was initiated on hospital day 7 for post-tace acute lung injury (ali).Hypoxemia resolved two days later.The patient's respiratory function completely normalized, but he continues to have significant pulmonary hypertension requiring medical therapy.The outcome of pulmonary embolism, right ventricular enlargement, tricuspid regurgitation, and post-tace ali are unknown.The patient subsequently underwent a successful liver transplant.Of note, the use of doxorubicin with lc bead is considered to be off-label use of a device.The authors did not provide an assessment regarding the severity of the events but did indicate the relatedness of acute hypoxemic respiratory failure, post-tace ali, and post-procedural pulmonary embolism with lc bead, doxorubin and lipiodol as documented "the acute hypoxemic respiratory failure following tace in our patient may have resulted from pulmonary embolism with doxorubicin-eluting beads and/or lipiodol.The known risk factors for post-tace pulmonary complications (e.G.Large hypervascular hcc, av shunts, large-volume lipiodol, and trans-inferior phrenic artery embolization) were all absent in our patient, making the post-tace ali in our patient an unexpected event." the authors did not indicate the relatedness of right ventricular enlargement, worsened pulmonary hypertension or worsened tricuspid regurgitation with the use of lc bead.The company assessed all of the events as serious with criteria of prolonged hospitalization and medically significant.Follow-up information has been sought.As of 24-feb-2016, no additional information has been received.The final report will be sent within 30 calendar days on 25-mar-2016.Company comment: the events of respiratory failure, acute lung injury, pulmonary hypertension, dilatation ventricular, and tricuspid valve incompetence are considered to be unlisted whereas post-procedural pulmonary embolism is listed according to lc bead current reference safety information.Off-label use of a device is unlisted.In agreement with the authors, the company considers respiratory failure, acute lung injury, and post-procedural pulmonary embolism as related to the use of lc bead and/or doxorubicin and lipiodol.In the absence of an assessment by the authors, the company considers pulmonary hypertension, dilatation ventricular, and tricuspid valve incompetence to be related to the use of lc bead until additional information can be obtained.The relatedness of off-label use of lc bead as doxorubicin-eluting is not assessable.This single case report does not modify the risk benefit balance of lc 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.

Event Description

Acute hypoxemic respiratory failure [respiratory failure].Post tace acute lung injury [acute lung injury].Worsened pulmonary hypertension [pulmonary hypertension].Mild right ventricular enlargement [dilatation ventricular].Worsened tricuspid regurgitation [tricuspid valve incompetence].Pulmonary embolism with doxorubicin eluting beads and or lipiodol [post procedural pulmonary embolism].Off-label use of lc bead as doxorubicin eluting [off label use of device].Case description: initial information received on 19-jan-2016: this spontaneous medical device report was received from a conference abstract entitled "an unexpected pulmonary complication following tace with low-dose doxorubicin-eluting beads and small-volume lipiodol for a small hcc" obtained from a literature review concerning a (b)(6) year old, male patient.The patient's medical history included (b)(6), cirrhosis, a new and small recurrent hepatocellular carcinoma (hcc), portopulmonary hypertension, and tricuspid regurgitation.The patient previously underwent a doxorubicin-eluting bead transarterial chemoembolization (deb-tace) for a 3.9-cm right hepatic lobe hcc (without complication) and resulted in tumor size reduction.Concomitant medications were not provided.The patient received doxorubicin (40 mg/5ml)- eluting 100-300 micron lc beads as a second deb tace for a small recurrent hcc (lot number and expiration date unknown) on an unknown date "seven months" after the first deb-tace (lot number and expiration date unspecified).The co-suspect agent lipiodol, 1 ml (manufacturer and indication unspecified) followed the deb-tace.On an unspecified date, the patient developed post-tace acute lung injury (ali), acute hypoxemic respiratory failure following tace which may have resulted from pulmonary embolism with doxorubicin-eluting beads and/or lipiodol, mild right ventricular (rv) enlargement, and worsened pulmonary hypertension with worsened tricuspid regurgitation.Immediately after the second deb-tace procedure, the patient developed hypoxemia (spo2 88%).Chest computerized angiography (cta) was negative for pulmonary embolism, but showed multiple bilateral areas of ground-glass opacities.Transthoracic echocardiogram (tte) showed mild right ventricular (rv) enlargement, worsened pulmonary hypertension with worsened tricuspid regurgitation.Patient was transferred to the intensive care unit (icu) on hospital day 3 for worsening respiratory distress, and was treated empirically with broad-spectrum antibiotics initially.A work up for infectious causes of acute hypoxemic respiratory failure was negative.Solumedrol was initiated on hospital day 7 for post-tace acute lung injury (ali).Hypoxemia resolved two days later.The patient's respiratory function completely normalized, but he continues to have significant pulmonary hypertension requiring medical therapy.The outcome of pulmonary embolism, right ventricular enlargement, tricuspid regurgitation, and post-tace ali are unknown.The patient subsequently underwent a successful liver transplant.Of note, the use of doxorubicin with lc bead is considered to be off-label use of a device.The authors did not provide an assessment regarding the severity of the events but did indicate the relatedness of acute hypoxemic respiratory failure, post-tace ali, and post-procedural pulmonary embolism with lc bead, doxorubin and lipiodol as documented "the acute hypoxemic respiratory failure following tace in our patient may have resulted from pulmonary embolism with doxorubicin-eluting beads and/or lipiodol.The known risk factors for post-tace pulmonary complications (e.G.Large hypervascular hcc, av shunts, large-volume lipiodol, and trans-inferior phrenic artery embolization) were all absent in our patient, making the post-tace ali in our patient an unexpected event." the authors did not indicate the relatedness of right ventricular enlargement, worsened pulmonary hypertension or worsened tricuspid regurgitation with the use of lc bead.The company assessed all of the events as serious with criteria of prolonged hospitalization and medically significant.Follow-up information has been sought.As of 24-feb-2016, no additional information has been received.The final report will be sent within 30 calendar days on 25-mar-2016.Follow-up information has been sought.As of 18-mar-2016, no additional information has been received.The final report will be sent within 30 calendar days on 22-apr-2016.Follow-up information has been sought.As of 18-apr-2016, no additional information has been received.This case is considered to be lost to follow-up.This report is final.Company comment: the events of respiratory failure, acute lung injury, pulmonary hypertension, dilatation ventricular, and tricuspid valve incompetence are considered to be unlisted whereas post-procedural pulmonary embolism is listed according to lc bead current reference safety information.Off-label use of a device is unlisted.In agreement with the authors, the company considers respiratory failure, acute lung injury, and post-procedural pulmonary embolism as related to the use of lc bead and/or doxorubicin and lipiodol.In the absence of an assessment by the authors, the company considers pulmonary hypertension, dilatation ventricular, and tricuspid valve incompetence to be related to the use of lc bead until additional information can be obtained.The relatedness of off-label use of lc bead as doxorubicin-eluting is not assessable.It has been assessed that no corrective action is necessary at this time and this report is final.This single case report does not modify the risk benefit balance of lc 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: LC 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 ; 4125273273
• MDR Report Key: 5398618
• MDR Text Key: 37112555
• Report Number: 3002124545-2016-00005
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K094018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100-300 ¼M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2016
• 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): Hospitalization; Other
• Patient Age: 62 YR