MAUDE Adverse Event Report: THORATEC CORPORATION VECTRA VASCULAR ACCESS GRAFT (D: 5MM, L: 40CM); PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number	10002-5020-003
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that on (b)(6) 2021 during dialysis, venous pressure increased and when contrast imaging was performed the area from the loop became invisible.A percutaneous transluminal angioplasty (pta) was performed the next day.The graft was occluded again a week later, and the occluded area was to be replaced.However, when the vein was incised and the graft was excised, the outer and inner layers were separated.The entire graft was therefore replaced.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the report of occlusion and peeling of the graft layers could not be confirmed.The customer reported that the graft was originally implanted on (b)(6) 2016.During dialysis on (b)(6) 2021, venous pressure increased and the area of the loop was not visible when contrast imaging was performed.The issue was addressed via percutaneous transluminal angioplasty but the graft became occluded again one week later.During surgery to replace the occluded area, the outer and inner layers of the graft reportedly became separated.The entire graft was subsequently replaced.No product was returned for investigation.The cause of the reported occlusion could not be determined.The vectra vag instructions for use cautions that when using a balloon angioplasty or embolectomy catheter within the lumen of the vectra vag, match the inflated balloon size to the inner diameter size of the vag.Over-inflation of the balloon or use of an inappropriately sized balloon catheter may damage the graft.Care must be exercised to avoid causing excessive axial elongation of the graft during retraction.The thrombectomy section of the ifu also states to follow the catheter manufacturer¿s instructions regarding size, selection, and balloon inflation, matching the balloon size to the inner diameter of the graft.Over-inflation and excessive pulling may dilate or damage the graft.Graft preparation and implantation are addressed in the vectra vascular access graft (vag) instructions for use (ifu).The precautions section states that when using a balloon angioplasty or embolectomy catheter within the lumen of the vectra vag, match the inflated balloon size to the inner diameter size of the vag.Over-inflation of the balloon or use of an inappropriately sized balloon catheter may damage the graft.Care must be exercised to avoid causing excessive axial elongation of the graft during retraction.The thrombectomy section states to follow the catheter manufacturer¿s instructions regarding size, selection, and balloon inflation, matching the balloon size to the inner diameter of the graft.Over-inflation and excessive pulling may dilate or damage the graft.If devices such as adherent clot catheter are used to declot the vectra grafts, it is important to match the catheter size to the internal diameter of the graft.If a longitudinal incision is used, place stay stitches at each end of the incision before introducing the embolectomy catheter.If a transversive incision is used, no stay stitch is necessary and a horizontal mattress suture technique will aid closure.Occlusion, stenosis, and thrombosis are listed as potential complications with the use of a vascular prosthesis.Intragraft obstruction is listed as a potential complication in table 2 in the summary of vectra vag clinical experience section of the ifu.Review of the device history records showed no deviations from manufacturing or qa specifications, including visual and dimensional inspection.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: VECTRA VASCULAR ACCESS GRAFT (D: 5MM, L: 40CM)
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 12426006
• Report Number: 2916596-2021-04563
• Device Sequence Number: 11766908
• Product Code: DSY
• UDI-Device Identifier: 00813024011316
• UDI-Public: 00813024011316
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K001927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 10002-5020-003
• Device Catalogue Number: 10002-5020-003
• Device Lot Number: 164178-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown