MAUDE Adverse Event Report: VASCUTEK LTD SEALPTFE; GELATIN SEALED EPTFE VASCULAR PROSTHESIS- STANDARD WALL

Model Number SEALPTFE

Device Problems Product Quality Problem (1506); Out-Of-Box Failure (2311); Delamination (2904)

Patient Problem No Information (3190)

Event Date 12/03/2015

Event Type  malfunction  

Manufacturer Narrative

Device discarded by physician - not returned to manufacturer.(b)(4).Method: as no grafts from original batch were available for testing, grafts from current production lots were retrieved and tested: two grafts from current production (1 with gelatin coating and 1 without) were cut at various angles and tested for peeling.Grafts were then manipulated to separate outer wrap and then wrap was peeled at right angle to graft as instructed in ifu and axially contrary to ifu.Grafts were then manipulated by stretching to try to delaminate ptfe wrap result: review of qc and manufacturing records showed this batch was manufactured to specification.Testing of grafts from production batches concluded that in the instance of the 2 grafts tested, peeling was difficult to achieve or indeed start without significant effort.There appeared to be no difference in graft performance between gelled and ungelled samples.Once peel was eventually started, twisting of the wrap as seen on the complaint graft could only be achieved by drawing tape axially along graft length contrary to ifu instructions.Conclusion: device not returned - actual device was discarded at hospital therefore no testing could be performed on actual device.From testing carried out on the grafts from production lots it was very difficult to recreate the failure reported.Due to the qc checks in place it would be highly unlikely that the graft left vascutek in condition received as indicated by images supplied by hospital.From the batch of (b)(4) grafts manufactured in 2012, (b)(4) were sent to (b)(6) and four (b)(4) were sent to (b)(6).The remaining (b)(4) were used as marketing samples.From the usage of these devices and from sales to these locations since 2012 it is believed all remaining grafts from these batches have been used without issue.No further complaints have been received from this batch.(b)(4).On this basis vascutek now considers this complaint closed.However this issue will be tracked and trended as part of the routine complaints monitoring and reporting process.If an adverse trend develops action will be taken at that time.

Event Description

After removal from sterile packaging it was found that a strip of the outer layer of ptfe wrap of the graft was peeled off from the outer wall.This graft was discarded without implantation.

• Brand Name: SEALPTFE
• Type of Device: GELATIN SEALED EPTFE VASCULAR PROSTHESIS- STANDARD WALL
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, scotland PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, scotland PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: carolyn forrest ; newmains avenue; inchinnan business park; renfrewshire, scotland PA4 9- RR ; UK PA4 9 RR ; 418125555
• MDR Report Key: 5356608
• MDR Text Key: 35948863
• Report Number: 9612515-2016-00001
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K993667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2015,01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2017
• Device Model Number: SEALPTFE
• Device Catalogue Number: S4005S
• Device Lot Number: P4246/2A 5159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/03/2015
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2015
• Date Manufacturer Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2012
• 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
• Patient Outcome(s): Required Intervention