MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® ACUSEAL VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Catalog Number ECH00640

Device Problem Occlusion Within Device (1423)

Patient Problem Reocclusion (1985)

Event Date 01/10/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2017, a gore® acuseal vascular graft was implanted into the patient¿s left underarm in order to perform dialysis treatments up to three times per week.It was reported to gore that on (b)(6) 2018, the patient was diagnosed with an occlusion of the gore® acuseal vascular graft.Subsequently, a thrombectomy was performed with a cleaner device from argon medical devices (6f ¿ 65cm x 9mm) followed by a percutaneous transluminal angioplasty with a 6mm x 40mm balloon.It was stated that the intervention achieved good results.One day after the reintervention procedure a reocclusion of the gore® acuseal vascular graft was noticed.Therefore an acute open surgery was performed where a small portion of the graft was explanted.A visual inspection of the explanted graft portion indicated a separation of the ptfe layers of the graft.It was reported that it is assumed that this separation caused the medical device occlusion.Consequently, the gore® acuseal vascular graft was disconnected but still remains in the patient next to a new implanted gore® acuseal vascular graft.It was stated that the patient was doing well following the procedure.

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.The device remains implanted, just one little portion of the graft was explanted and visually inspected by the hospital.As this portion was discarded afterwards, an engineering evaluation could not be performed.

• Brand Name: GORE® ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7269220
• MDR Text Key: 99986614
• Report Number: 2017233-2018-00100
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2019
• Device Catalogue Number: ECH00640
• Device Lot Number: 5381427PP013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2016
• 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
• Patient Age: 53 YR
• Patient Weight: 70