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

Model Number	10002-5020-003
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the extraction site was a non-punctured area with no history of percutaneous transluminal angioplasty (pta).The patient was implanted with 5mm 20cm dense reinforcement type and polytetrafluoroethylene (ptfe) composite.An obstruction was confirmed by echocardiography and was removed because a layer deviation was found.The patient underwent reoperation on (b)(6)2023 and was repaired again with 5mm 20cm dense reinforcement.
Event or Problem Description
The patient was implanted with 5mm 20cm dense reinforcement type and polytetrafluoroethylene (ptfe) composite on (b)(6) 2020.An obstruction was confirmed on (b)(6) 2023 by echocardiography and was removed because a layer deviation was found.The patient underwent reoperation on (b)(6) 2023 and the vectra graft was replaced with a new one.
Additional Manufacturer Narrative
A1-a4: patient initials, date of birth, and weight were requested but not provided.A2: patient age has been estimated based on a provided age range.Manufacturer's investigation conclusion: the report of a graft obstruction could not be confirmed.The customer reported that the vectra graft was implanted in (b)(6) 2020.An obstruction occurred on (b)(6) 2023, which was confirmed via echocardiography.The location had no history of puncture or percutaneous transluminal angioplasty (pta).It was reported that a ¿layer deviation¿ was found and the graft was replaced with another vectra graft.Photographs of the explanted vectra graft were submitted for review.The images showed graft had been cut open longitudinally.It was noted that the graft layers had become separated, however, it could not be determined if this was the result of the graft being cut, handling, or another unknown cause.No graft obstruction was visible in the photographs.The relevant sections of the device history records were reviewed and showed no deviations from mfg or qa specifications.Vectra vascular access graft (vag) instructions for use (ifu) lists occlusion, stenosis, and thrombosis 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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: VECTRA VASCULAR ACCESS REVISION GRAFT
• 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: 17039595
• Report Number: 2916596-2023-03453
• Device Sequence Number: 6908590
• Product Code: DYF
• 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
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/29/2024
• Device Model Number: 10002-5020-003
• Device Catalogue Number: 10002-5020-003
• Device Lot Number: 6877537
• 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: 05/26/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2019
• 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; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male