MAUDE Adverse Event Report: COOK INC PVA FOAM EMBOLIZATION PARTICLES; AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS

Catalog Number UNKNOWN

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

Patient Problem Abscess (1690)

Event Date 04/04/2016

Event Type  Injury  

Event Description

It was discovered during a literature review of an observational study titled "liver abscess formation following transarterial chemoembolization" related to a retrospective review of patients from 2005 to 2013, that liver abscesses were found in 21 out of 3613 patients who had undergone a transarterial chemoembolization (tace) procedure.The patients had hepatic malignancies.Among the 21 patients, 15 were males and 6 were females, ranging in age from 41 to 73 years (mean 54.6).

Manufacturer Narrative

Investigation ¿ evaluation.A review of the interview personnel, documentation and instructions for use (ifu) of the device was conducted during the investigation.Clinical assessment: based on current information, it is feasible to suggest the leading cause of this event is likely patient medical procedure and/or patient disease progression related.The product was not returned, thus a device failure analysis could not be completed.The lot number for this complaint device is unknown.Consequently, the work order record or its related non-conformances could not be evaluated.Additionally, it could not be determined if other complaints from the same lot have been reported.Based on additional information and published study results, it was concluded that the device did not cause or contribute to the patient liver abscesses.It was also stated in the additional information that the product did not malfunction in any way.Due to the lack of device involvement in the failure mode described, this complaint is considered unconfirmed.At this time there is no specific device failure or harm reported, therefore no risk assessment can be performed and no risk severity can be assigned.If additional information becomes available, the risk assessment will be updated.

Event Description

It was discovered during a literature review of an observational study titled "liver abscess formation following transarterial chemoembolization" related to a retrospective review of patients from 2005 to 2013, that liver abscesses (most common bacterium e.Coli) were found in 21 out of 3613 patients who had undergone a transarterial chemoembolization (tace) procedure.The patients had hepatic malignancies.Among the 21 patients, 15 were males and 6 were females, ranging in age from 41 to 73 years (mean 54 years).Nine of these patients had hepatocellular carcinoma (hcc), and 12 had metastatic hepatic tumor (mht).A higher incidence of liver abscess was found in mht patients than in hcc patient.Among these abscess patients, 16 presented with upper abdominal pain, 13 experienced a high-grade fever, and 9 had vomiting and nausea.During the physical examination, 11 experienced tenderness in their right upper abdomen, and 8 had localized guarding.The 21 patients were treated with sensitive antibiotics accordingly based on sensitivity test results.The abscess cavity was irrigated once a day for 3 to 5 days after percutaneous catheter drainage (pcd).It was noted that three patients needed 2 drainages and 2 needed 3 drainages.The patients were closely monitored using either abdominal ct scans or ultrasonography every 7 to 10 days until the abscesses were cured or became less than 2 cm in size.Finally, the drainage catheter was pulled out.A total of 20 patients were completely cured from abscesses 15 to 31 days after pcd, but 1 patient died of severe sepsis 9 days after pcd (reference mdr# 1820334-2017-03274).After discharge, all patients were followed up for at least 3 months.Two patients developed complications following pcd: 1 had abscess cavity-bile duct fistula (reference mdr# 1820334-2017-03269), and the other had localized peritonitis reference ( reference mdr# 1820334-2017-03476).No abscess recurrence was observed in all of these patients.This report is created to address the 350 to 510 micron polyvinyl alcohol (pva) particles which were reportedly employed in the tace procedures.For the report addressing the angiographic catheter which was also used in conjunction with the same patient population, please reference mdr# 1820334-2017-03266.It is currently unknown which patients of the 21 had which complications.Additional information has been requested.No allegations of any product malfunction have been alleged.The product is not available for evaluation.Additional information received on 09 nov2017.It was identified per the regional manager involved in the study, "the research was carried out more than 10 years and the objective was to understand the implication of tace and not patient demographic.The cook rh catheter did not cause or contribute to the patients liver abscesses.It is not certain what specific cook rh catheters were used in these procedures.The cook polyvinyl alcohol particles did not cause or contribute to the patients liver abscesses.It cannot be confirmed that cook polyvinyl alcohol particles were used in these procedures.The product did not malfunction in anyway.There are no photos available.Some liver abscesses developed only after the tace procedure and depending on the certain patients outcome after the tace procedure.Medical records are not available as it was more than 10 years".

• Brand Name: PVA FOAM EMBOLIZATION PARTICLES
• Type of Device: AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6947602
• MDR Text Key: 89288878
• Report Number: 1820334-2017-03482
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2017
• Supplement Dates Manufacturer Received: 11/09/2017
• Supplement Dates FDA Received: 12/07/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention