MAUDE Adverse Event Report: VASCUTEK LTD. GELSOFT PLUS; GELATIN IMPREGNATED KNITTED VASCULAR PROSTHESIS

Model Number GELSOFT PLUS

Device Problems Material Puncture/Hole (1504); Material Perforation (2205); Material Integrity Problem (2978)

Patient Problem Pseudoaneurysm (2605)

Event Type  malfunction  

Manufacturer Narrative

No serial number provided.Explanted date - explant date only provided as (b)(6) 2018.No day supplied - vascutek is awaiting confirmation of the exact date.As above vascutek is awaiting confirmation of exact date of event / explant.(b)(4).

Event Description

Event was reported to vascutek rep on (b)(6) 2018 as follows: gelsoft graft was implanted on (b)(6) 2014 to replace 2 previously implanted ptfe grafts (no details provided) in the same position which had both occluded.The graft was explanted as the doctor had observed dilatation of the graft and replaced with another graft (no details provided).

Manufacturer Narrative

Conclusion code - 11 - conclusion not yet available - vascutek has requested further information from site regarding use of the graft during its lifetime.Vascutek will report findings in next follow up / final report.

Manufacturer Narrative

Manufacturers narrative.Section h6.Conclusion code - 4315 - cause not established - the cause of the holes leading to the pseudoaneurysm could not be determined from investigation of returned device, from review of qc and manufacturing record or from information supplied from the site.Initial report for this complaint was for dilatation however on investigation the returned sample was determined to be pseudoaneurysm.A similar event review was carried out initially for dilatation and a subsequent search for aneurysm/pseudoaneurysm.There was only one additional event for each mode each giving an occurrence rate of 0.001% for aneurysm / pseudoaneurysm.0.002% for dilatation.(complaint v sales).Review of qc, manufacturing and physical testing records show batch was manufactured to specification and all physical testing of material met acceptance criteria.Vascutek made several documented attempts to gather further information from site regarding any intervention or treatment that may have been administered during the 4 years the device was implanted.No further information was however received.It is therefore unknown what led to the holes which developed on the graft during this period.Further action is not planned, however, the issue will be tracked and trended as part of the on-going complaints trending and reporting process and if an adverse trend develops action may be taken at that time.Vascutek ltd.Now considers this complaint closed.

• Brand Name: GELSOFT PLUS
• Type of Device: GELATIN IMPREGNATED KNITTED VASCULAR PROSTHESIS
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 7955136
• MDR Text Key: 123834539
• Report Number: 9612515-2018-00018
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K955230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2018,11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: GELSOFT PLUS
• Device Catalogue Number: 634008P
• Device Lot Number: 308134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Was the Report Sent to FDA?: No
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2018
• Date Manufacturer Received: 09/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR