MAUDE Adverse Event Report: VASCUTEK LTD. GELSOFT ERS; GELSOFT EXTERNALLY REINFORCED STRAIGHT

Model Number GELSOFT ERS

Device Problems Degraded (1153); Peeled/Delaminated (1454); Material Puncture/Hole (1504); Material Perforation (2205); Material Integrity Problem (2978)

Patient Problem Pseudoaneurysm (2605)

Event Date 08/20/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided.No device serial no.Or batch/lot no.Provided.No device details supplied therefore exact year of manufacture is unknown however device was implanted on (b)(6) 2006.(b)(4).An occurrence rate of (b)(4) was determined for all complaints v sales for gelsoft and gelsoft plus.An occurrence rate of (b)(4) was determined for gelsoft only events.An occurrence rate of (b)(4) was determined for gelsoft plus only events.Results of investigation will be reported in next follow up / final report.

Event Description

Event was reported to vascutek ltd.As follows: graft was implanted on (b)(6) 2006 without incident.On (b)(6) 2018 patient complained of swelling at top end of upper leg.Ct inspection was performed and a false aneurysm was found.On (b)(6) 2018 a procedure was performed.Two sections of the peelable support were found to be detached and approximately 1cm of tears / rips were observed.These sections were removed.The removed section was replaced with an alternative product.And procedure was completed.No device serial no.Or batch / lot no.Was provided.

Manufacturer Narrative

Incomplete device returned - the sample returned from the site was incomplete.The returned decontaminated sample was too small and had been cut along its length (approx.15mm of a 60cm graft) therefore no viable testing of material or support could be performed.No finding available - vascutek could not perform a batch review as no batch details were supplied and no viable testing could be performed on returned sample therefore no findings could be derived from information received cause not established - as no testing could be performed on returned sample vascutek could not establish a root cause of the reported event.Vascutek was also informed that no further device information could be supplied therefore no review of batch qc and manufacturing records could be performed.As this device was implanted in 2006 and shelf life is five years this device could not have been manufactured prior to 2001.A review of vascutek complaint database from 2000 to present date only showed 1 additional complaint for this catalogue number 670006 in 2007, however this was not for the same failure mode.No further complaints for this catalogue number have been received for this failure mode to date.Vascutek could not determine a root cause for this event.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.As no further information will be supplied and no testing could be performed on returned sample vascutek now considers this complaint closed.(b)(4).

• Brand Name: GELSOFT ERS
• Type of Device: GELSOFT EXTERNALLY REINFORCED STRAIGHT
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 7884304
• MDR Text Key: 120711055
• Report Number: 9612515-2018-00014
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K002007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/24/2018,10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GELSOFT ERS
• Device Catalogue Number: 670006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/21/2018
• Device Age: 12 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2018
• Date Manufacturer Received: 08/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention