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

Device Problem Material Rupture (1546)

Patient Problem Vascular Dissection (3160)

Event Date 04/07/2020

Event Type  Injury  

Manufacturer Narrative

Date of event was defined as the date when the article was published.The literature article ¿dissection of a shunt prosthesis: visual diagnosis on duplex ultrasound¿, published by yousefi o et al, within the ¿gefässchirurgie¿ journal was received and processed.Product surveillance coordinator requested additional information from the author where feedback was received that no further information will be shared.

Event Description

Within the article ¿dissection of a shunt prosthesis: visual diagnosis on duplex ultrasound¿, published by yousefi o et al, within the ¿gefässchirurgie¿ journal, the article indicates the following: the following case report describes the diagnostic procedure and treatment strategy for an acute loop shunt closure in the patient¿s thigh, resulting from early shunt puncturing.Due to a lack of suitable vein material in a (b)(6) dialysis patient, an arteriovenous prosthetic loop shunt (gore® acuseal vascular graft, 6 mm) was implanted in the patient¿s right thigh.The article states that a duplex sonography revealed a longitudinal dissection of one portion of the implanted prosthesis (4 cm long) in the arterial part section.The remaining parts of the prosthesis were normal and intact.The dissection was confirmed intraoperatively.In another procedure a new prosthesis segment was implanted (bard venaflo® ll vascular graft, straight, 6 mm).The postoperative course was straightforward and the patient was discharged on time.Dissection of an early-puncturable shunt prosthesis is a rare complication.A similar problem has not been previously described in the literature.In the case of shunt occlusions occurring in an early-puncturable the presence of a dissection must be excluded.

• 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: gunter marte ; 1500 n. 4th street; 9285263030
• MDR Report Key: 10084998
• MDR Text Key: 193302790
• Report Number: 2017233-2020-00384
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• 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: 38 YR