MAUDE Adverse Event Report: THORATEC CORPORATION VECTRA VASCULAR ACCESS GRAFT WITH GRADUATED REINFORCEMENT; PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER

Model Number	10002-5040-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event	08/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a vectra vascular access graft implanted on (b)(6) 2022.Initial puncture and dialysis was performed on (b)(6) 2022.After dialysis, the need was removed, without resistance, and gauze was applied to stop the bleeding.When the gauze was removed, a thread-like substance came out of the puncture wound.The substance was cut and the artificial blood vessel was still in use.
Additional Manufacturer Narrative
No additional information has been provided.A supplemental report will be submitted one the manufacturer's investigation is complete.
Additional Manufacturer Narrative
This event occurred at (b)(6) hospital in (b)(6) japan.Manufacturer's investigation conclusion: the reported event was determined to be unrelated to the vectra graft.It was reported that 12 days after the graft was implanted, gauze was applied to the needle puncture site at the conclusion of dialysis treatment.A thread-like material appeared to be protruding from the needle hole when the gauze was removed.The thread was cut at the skin line and retained for analysis.The analysis report received from the distributor (b)(4) concluded that the thread-like material was human in origin and not a piece of the graft.The report presumed that tissue was pulled out of the patient¿s body when the needle was removed.There is no product related issue associated with this event.Review of the device history records showed no deviations from manufacturing or quality assurance specifications, including visual and dimensional inspection.Graft preparation and implantation are addressed in the vectra vascular access graft (vag) instructions for use (ifu).The cannulation section of the ifu states that vectra grafts may be punctured for vascular access within 24 hours after implant, provided no contraindications are present.If the blood access needle is inserted such that the angle between the needle axis and the graft is too small, tears in the wall of the graft can occur.This section advises to rotate cannulation sites.Repeated cannulation in the same area may lead to damage of the graft wall and/or formation of hematoma or pseudoaneurysm.Needle sites should be equally spaced along the subcutaneous length of the graft.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that the patient had a vectra vascular access graft implanted on (b)(6) 2022.Initial puncture and dialysis were performed on (b)(6) 2022.After dialysis, the needle was removed, without resistance, and gauze was applied to stop the bleeding.When the gauze was removed, a thread-like substance came out of the puncture wound.The substance was cut, and the artificial blood vessel was still in use.Additional information reported that the thread-like material was human in origin and not a piece of the graft.

• Brand Name: VECTRA VASCULAR ACCESS GRAFT WITH GRADUATED REINFORCEMENT
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM 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: 15538806
• Report Number: 2916596-2022-13971
• Device Sequence Number: 6073801
• Product Code: DYF
• UDI-Device Identifier: 00813024011323
• UDI-Public: 00813024011323
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K001927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/08/2024
• Device Model Number: 10002-5040-001
• Device Catalogue Number: 10002-6050-001
• Device Lot Number: 7173628
• 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: 09/14/2022
• Supplement Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2019
• 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; Other
• Patient Sex: Unknown