MAUDE Adverse Event Report: VASCUTEK GELSOFT PLUS BIFURCATED GRAFT

Catalog Number 631608P

Device Problem Hole In Material (1293)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Method: (b)(4) - actual device remains in situ within the patient therefore it was not possible to evaluate the complaint device; (b)(4) - a complete review of the qc and manufacturing records was carried out.The review confirmed that the device was manufactured to specification.Conclusion: (b)(4) - as the actual device was not returned it was not possible to confirm the complaint.The review of the manufacturing and qc records showed that the device was manufactured to the specifications and no failure could be identified vascutek's rate of leakage at the bifurcation site is very low and sits well below any trigger levels for action.Additionally vascutek's overall leakage rates are well below industry expectations.The event type will continue to be tracked and trended through the complaints monitoring system.If a negative trend is identified corrective action will be considered at this time.Vascutek now considers this complaint to be closed.Not returned to manufacturer.

Event Description

Vascutek have been notified of an event involving a gelsoft device where a hole was noticed between the legs of a bifurcated graft.After the graft had been sutured to the aorta at the proximal end.The surgeon sutured the hole and the device remains in situ, the patient's post operative condition is stable.

• Brand Name: GELSOFT PLUS BIFURCATED GRAFT
• Type of Device: GELSOFT PLUS
• Manufacturer (Section D): VASCUTEK; newmains ave; inchinnan business park; renfrewshire, scotland PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK; newmains ave; inchinnan business park; renfrewshire, scotland PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: carolyn forrest ; newmains ave; inchinnan business park; renfrewshire, scotland PA4 9-RR ; UK PA4 9RR ; 4141812555
• MDR Report Key: 5155458
• MDR Text Key: 28439545
• Report Number: 9612515-2015-00028
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K955230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 09/17/2015,10/16/2015

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: 07/31/2020
• Device Catalogue Number: 631608P
• Device Lot Number: 364249 7966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2015
• 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