MAUDE Adverse Event Report: VASCUTEK LTD. VP1200K; VP1200K BIFURCATE

Model Number	VP1200K
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted; therefore, no evaluation of actual device could be performed.(b)(4).Method - no testing methods performed - no testing of actual device possible as graft remains implanted in patient.Process evaluation - review of manufacturing and qc records to ensure batch processed as per specification.Manufacturing review - review of retained manufacturing and quality records.Results- no failure detected - review of retained qc and manufacturing record show batch was manufactured to specification.Conclusion- conclusion not yet available as evaluation still in progress - vascutek has requested further information from site related to event and will report findings in next follow up / final report.
Event or Problem Description
Event was reported to vascutek as follows; approximately 2 weeks after the implant, the surgeon observed a large increase of the diameter of the main body section of the bifurcation from 16mm to approx.24mm.
Additional Manufacturer Narrative
Additional manufacturers narrative.Unable to confirm complaint - without return of device and further information or ct images of event vascutek are unable to confirm complaint or investigate further.Vascutek received information that ct scans were performed on (b)(6) 2016 but no additional intervention was required.No patient consequences were reported.Vascutek has carried out a 5 year review for similar events which confirmed that there have been no other dilatation complaints received for vp1200k devices, giving an occurrence rate of (b)(4)% and showing no adverse trends.From a clinical perspective such a quick and large % of dilatation is unusual and could be potentially serious, however graft dilatation post implantation is a frequent occurrence which does not necessarily indicate that there will be a rupture or failure of the graft (as in this case there was no patient consequences reported).Vascutek now considers this complaint closed, however the issue will be tracked and trended as part of the routine complaints monitoring and reporting process.If an adverse trend develops action may be taken at that time.
Event or Problem Description
This report is being submitted as a follow up / final report for mfr report # 9612515-2016-00017 to provide additional information regarding the event and vascutek's investigation.

• Brand Name: VP1200K
• Common Device Name: VP1200K BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, scotland PA4 9 RR; UK PA4 9RR
• MDR Report Key: 5675258
• Report Number: 9612515-2016-00017
• Device Sequence Number: 172003
• Product Code: DSY
• UDI-Device Identifier: 05037881020488
• UDI-Public: 05037881020488
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K910866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2016
• Report Date (Section F): 04/25/2016

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
• Operator of Device: Physician
• Device Expiration Date: 10/31/2020
• Device Model Number: VP1200K
• Device Catalogue Number: 321608
• Device Lot Number: 370647
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/01/2016
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2016
• Supplement Report FDA Received Date: 06/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR