MAUDE Adverse Event Report: VASCUTEK LTD. SEALPTFE; GELATIN SEALED EPTFE VASCULAR PROSTHESIS

Model Number SEALPTFE

Device Problems Degraded (1153); Peeled/Delaminated (1454); Material Integrity Problem (2978)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method code - historical data analysis - 5-year review of previous complaints for gelatin issues was performed.Method code - analysis of production records - review of retained qc, manufacturing and physical test data was performed.Method code - device not returned - the device was not returned as it was contaminated with patient blood who had (b)(6) viral infection.Results code - results pending completion of investigation - vascutek is awaiting further information from site regarding event.Conclusion code - conclusion not yet available - vascutek is awaiting further information from site.Vascutek will report findings in next follow up / final report.

Event Description

The event was reported to vascutek on (b)(6) 2018 as follows: "gelatin was separated.The graft was sutured to a blood vessel as a shunt.After one side of the graft was sutured to the blood vessel according to the ifu, when the other side was cut off to be implanted its gelatin was separated( scattered).The graft was removed from the patient and replaced with two sealptfe grafts cat no.S2005s.The replacement grafts were implanted without any issue." site has reported no health issue for patient.

Manufacturer Narrative

(b)(4).A review of retained manufacturing and qc test records confirmed that the batch containing the complaint device was manufactured to specification.Grafts passed all physical testing and porosity testing.Of the 7 grafts manufactured in this batch 5 have been implanted and 2 remain on consignment at this time.This complaint was the only one received for this batch to date.A review of similar events was completed for 5-year period which gave a low occurrence rate of 0.003% (complaints v sales) this is the only complaint for gelatin separating.No other complaints have been received for units of the same batch.No issues or adverse trends were noted during the preliminary investigation.No graft was returned for investigation and no further information was received which could aid in determining a root cause of this event.Vascutek now considers this complaint closed.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.

• Brand Name: SEALPTFE
• Type of Device: GELATIN SEALED EPTFE VASCULAR PROSTHESIS
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 7913462
• MDR Text Key: 121864271
• Report Number: 9612515-2018-00015
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881002736
• UDI-Public: 05037881002736
• Combination Product (y/n): N
• PMA/PMN Number: K993667
• 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: 08/31/2018,10/25/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: SEALPTFE
• Device Catalogue Number: S2005S
• Device Lot Number: 17273996
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/31/2018
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2018
• Initial Date Manufacturer Received: 08/31/2018
• Initial Date FDA Received: 09/27/2018
• Supplement Dates Manufacturer Received: 08/31/2018
• Supplement Dates FDA Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other