MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD THERASPHERE; SINGLE USE IMPLANTABLE MEDICAL DEVICE

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Death (1802); Fatigue (1849); Liver Damage/Dysfunction (1954); Nausea (1970); Pain (1994); Weakness (2145); Jaundice (2187); Abdominal Distention (2601); Polydipsia (2604); Weight Changes (2607)

Event Date 05/23/2017

Event Type  Death  

Event Description

Progressive liver failure [hepatic failure], increased weakness/generalized weakness [asthenia], abdominal bloating [abdominal distension], decreased po intake [hypophagia], weight loss [weight decreased], loss of appetite [decreased appetite], persistent thirst [thirst], back ache [back pain], fatigue [fatigue], right sided abdominal pain [abdominal pain], nausea [nausea], case description: initial information received on 30-may-2017: this spontaneous medical device report was received from a nurse concerning a (b)(6) female patient.The patient's medical history included ductal carcinoma in situ (dcis) diagnosed in 2014, metastatic breast cancer with metastases in axial skeleton, pleural space, supraclavicular nodes, left axillary nodes and liver as well as both ovaries, all diagnosed in late 2015/early 2016.The patient's concomitant medication included letrozole since (b)(6) 2016 for treatment of metastatic disease, palbociclib since (b)(6) 2016 (held during y90 treatment) for treatment of metastatic disease and denosumab since (b)(6) 2016 for an unknown indication.On (b)(6) 2017, the patient was treated with y90/theraspheres (dosage, lot number and expiration date not reported) for breast cancer with metastatic liver disease.Standard vetting of the patient was performed prior to the procedure in order to reduce the risk of radioembolization-induced liver disease.The patient did fairly well after the treatment, complaining of fatigue [fatigue] and some right sided abdominal pain [abdominal pain] which resolved at the time of the second treatment.On (b)(6) 2017, the patient was treated again with y90/theraspheres (dosage, lot number and expiration date not reported) for breast cancer with metastatic liver disease.On an unspecified date in 2017, after the second treatment, the patient did complain of abdominal bloating [abdominal distension] and weight loss [weight decreased].On (b)(6) 2017, mri and ct scans showed improvement of the liver disease but cirrhotic changes as well as ascites.The patient was treated with supportive care in the form of paracentesis and diuretics (spironolactone and furosemide).The patient was noted to be jaundiced.All relevant laboratory results have been entered in the dedicated section.On (b)(6) 2017 the patient presented to the emergency room with increased weakness [asthenia], decreased po intake [hypophagia] and abdominal bloating [abdominal distension].She also reported associated loss of appetite [decreased appetite], nausea [nausea], persistent thirst [thirst], generalized weakness [asthenia], mild right sided abdominal pain [abdominal pain] and back ache [back pain].She was admitted to the hospital for supportive care but her condition worsened.On (b)(6) 2017 the patient died due to progressive liver failure [hepatic failure].The outcome of all events except fatigue and progressive liver failure was unknown.The reporter did not provide an assessment of the events seriousness but assessed the event hepatic failure related to therasphere treatment as it was felt that, based on timing of events and imaging findings, it was most likely radioembolization-induced liver disease.The reporter did not provide an assessment of the seriousness or causality of the events asthenia, abdominal distension, hypophagia, weight decreased, decreased appetite, thirst, back pain, fatigue, abdominal pain and nausea to the therasphere treatment.Cirrhotic changes, ascites and jaundice have been subsumed within hepatic failure.The company assessed the event hepatic failure as serious (death) and all other events as non-serious.Follow-up information will be requested.Case comment: hepatic failure, abdominal pain and nausea were considered anticipated according to therasphere current reference safety information, whereas asthenia, abdominal distension, hypophagia, weight decreased, decreased appetite, thirst and back pain where unanticipated.In agreement with the assessment made by the reporting nurse, the company considered that hepatic failure was related to the administration of therasphere.In absence of an assessment made by the reporter, the company considered that asthenia, abdominal distension, hypophagia, weight decreased, decreased appetite, thirst, back pain, fatigue, abdominal pain and nausea were related to the administration of therasphere since its role cannot be ruled out, although they could also be related to underlying disease of the patient.There was no report of device failure or malfunction.

Manufacturer Narrative

(b)(4).

Event Description

Progressive liver failure [hepatic failure], increased weakness/generalized weakness [asthenia], abdominal bloating [abdominal distension], decreased po intake [hypophagia], weight loss [weight decreased], loss of appetite [decreased appetite], persistent thirst [thirst], back ache [back pain], treated with therasphere for liver mets from metastatic breast cancer [off label use of device], fatigue [fatigue], right sided abdominal pain [abdominal pain], nausea [nausea].Case description: initial information received on (b)(6) 2017: this spontaneous medical device report was received from a nurse concerning a (b)(6)-year old female patient.The patient's medical history included ductal carcinoma in situ (dcis) diagnosed in 2014, metastatic breast cancer with metastases in axial skeleton, pleural space, supraclavicular nodes, left axillary nodes and liver as well as both ovaries, all diagnosed in late 2015/early 2016.The patient's concomitant medication included letrozole since (b)(6) 2016 for treatment of metastatic disease, palbociclib since (b)(6) 2016 (held during y90 treatment) for treatment of metastatic disease and denosumab since (b)(6) 2016 for an unknown indication.On (b)(6) 2017, the patient was treated with y90/theraspheres (dosage, lot number and expiration date not reported) for breast cancer with metastatic liver disease [off label use of device].Standard vetting of the patient was performed prior to the procedure in order to reduce the risk of radioembolization-induced liver disease.The patient did fairly well after the treatment, complaining of fatigue [fatigue] and some right sided abdominal pain [abdominal pain] which resolved at the time of the second treatment.On (b)(6) 2017, the patient was treated again with y90/theraspheres (dosage, lot number and expiration date not reported) for breast cancer with metastatic liver disease.On an unspecified date in 2017, after the second treatment, the patient did complain of abdominal bloating [abdominal distension] and weight loss [weight decreased].On (b)(6) 2017, mri and ct scans showed improvement of the liver disease but cirrhotic changes as well as ascites.The patient was treated with supportive care in the form of paracentesis and diuretics (spironolactone and furosemide).The patient was noted to be jaundiced.All relevant laboratory results have been entered in the dedicated section.On (b)(6) 2017 the patient presented to the emergency room with increased weakness [asthenia], decreased po intake [hypophagia] and abdominal bloating [abdominal distension].She also reported associated loss of appetite [decreased appetite], nausea [nausea], persistent thirst [thirst], generalized weakness [asthenia], mild right sided abdominal pain [abdominal pain] and back ache [back pain].She was admitted to the hospital for supportive care but her condition worsened.On (b)(6) 2017 the patient died due to progressive liver failure [hepatic failure].The outcome of all events except fatigue and progressive liver failure was unknown.The reporter did not provide an assessment of the events seriousness but assessed the event hepatic failure related to therasphere treatment as it was felt that, based on timing of events and imaging findings, it was most likely radioembolization-induced liver disease.The reporter did not provide an assessment of the seriousness or causality of the events asthenia, abdominal distension, hypophagia, weight decreased, decreased appetite, thirst, back pain, fatigue, abdominal pain and nausea to the therasphere treatment.Cirrhotic changes, ascites and jaundice have been subsumed within hepatic failure.The company assessed the event hepatic failure as serious (death) and all other events as non-serious.Follow-up information will be requested.Case comment: hepatic failure, abdominal pain and nausea were considered anticipated according to therasphere current reference safety information, whereas asthenia, abdominal distension, hypophagia, weight decreased, decreased appetite, thirst, back pain and off label use of device where unanticipated.In agreement with the assessment made by the reporting nurse, the company considered that hepatic failure was related to the administration of therasphere.In absence of an assessment made by the reporter, the company considered that asthenia, abdominal distension, hypophagia, weight decreased, decreased appetite, thirst, back pain, fatigue, abdominal pain and nausea were related to the administration of therasphere since its role cannot be ruled out, although they could also be related to underlying disease of the patient.Off label use of device is not an adverse event per se but a special scenario and therefore not assessable.There was no report of device failure or malfunction.

• Brand Name: THERASPHERE
• Type of Device: 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: sandra bausback ; lakeview, riverside way; watchmoor park; camberley, surrey GU15 -3YL ; UK GU15 3YL ; 61033
• MDR Report Key: 6672855
• MDR Text Key: 78566822
• Report Number: 3002124543-2017-00035
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2017
• 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
• Treatment: DENOSUMAB; PALBOCICLIB
• Patient Outcome(s): Death
• Patient Age: 48 YR