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	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
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 the echocardiogram confirmed linear material in the graft lumen which was removed with biopsy forceps.The reinforcing thread was severed by a puncture operation at the dialysis facility.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the report of a reinforcing thread in the lumen of the graft could not be confirmed.The customer reported that a linear material was observed in the lumen of the graft via echocardiography.It was indicated that this was the third occurrence of this observation with the patient and was believed to be caused by the graft being punctured during dialysis.The material was removed using biopsy forceps.A photograph and infrared spectrum were provided for review.The photo appeared to show a strand of material consistent with the reinforcing monofilament.The provided spectrum was dated (b)(6) 2022 and was reportedly comparing the material removed from the patient¿s graft to a sample of the monofilament, which appeared to be a match.However, the files provided for review appeared to be from one of the patient¿s prior incidents and not the event on (b)(6) 2022.The vectra vascular access graft instructions for use 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.The device history records could not be reviewed because the lot number of the graft was reported to be unknown.Graft preparation and implantation are addressed in the vectra vascular access graft (vag) instructions for use (ifu).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.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.

• 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: 16043322
• Report Number: 2916596-2022-16046
• Device Sequence Number: 11986010
• Product Code: DYF
• UDI-Device Identifier: 00813024011453
• UDI-Public: 00813024011453
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 10002-5040-001
• Device Catalogue Number: 10002-6050-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 12/23/2022
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown