MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE-TEX® VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Catalog Number SB1401

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 08/02/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The following information was received through literature ¿congenital abdominal aortic aneurysm in a term neonate: a case report¿ published by asian biomedicine, volume 11 (2017): issue 2 (april 2017).The case was to report a female thai infant was born spontaneously at term (3,990 g) having a large, pulsatile, abdominal mass.Computed tomographic angiography (cta) of the abdominal aorta showed a large infrarenal aaa, and a fusiform aneurysm at the left common iliac artery.Two small right renal arterial aneurysms were also noted.The large aneurysm was partially resected and a gore-tex vascular graft was placed at 15 days old.Histopathology of the aneurysmal wall revealed no specific etiology.Ultrasonography revealed thrombosis of the graft on the 13th day after surgery.Repeated cta of the abdominal aorta at age (b)(6) showed complete thrombosis of the graft with reconstitution of collateral circulation.The infrarenal aaa and left common iliac aneurysm and 2 small right renal artery aneurysms were completely thrombosed.The patient grew and developed normally to the most recent follow up at age (b)(6).

Manufacturer Narrative

Additional information provided by author, therefore a2/b3/d4 updated.

Manufacturer Narrative

Literature citation: literature ¿limb preservation by gore-tex vascular graft for groin recurrence after postoperative adjuvant radiation in vulvar cancer¿ published by academic press, gynecologic oncology 82, 559¿562 (2001).The authors: anongnart sirisaby, panruethai trinavarat, jule namchaisiri, santi punnahitanond, pimolratthaithumyanon king chulalongkorn memorial hospital, 13 rama iv rd, pathum wan, pathum wan district, bangkok 10330, thailand.Anongnart.Si@chula.Ac.Th.

Manufacturer Narrative

Update g4.

Manufacturer Narrative

H6: 213-a review of the manufacturing records indicated the lots met all pre-release specifications.

• Brand Name: GORE-TEX® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: pixie xi ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11918212
• MDR Text Key: 264313442
• Report Number: 2017233-2021-02044
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K904282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2014
• Device Catalogue Number: SB1401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 15 DA
• Patient Sex: Female
• Patient Weight: 4 KG