MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS; ENDOVASCULAR GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Renal Failure (2041); Thrombosis (2100)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records could not be performed as device item/lot numbers were not available.The images and device were not available, the imaging evaluation and engineering evaluation could not be performed.

Event Description

The following publication was reviewed: "retrospective evaluation of the endovascular repair of the anastomotic pseudoaneurysm of the transplanted renal artery using the snorkel technique" through "vascular 0(0) 1¿6 the author(s) 2020".The authors are che haijie, song fubo, li xiaoying, yu ying and pu zenghui.The article aimed to evaluate the endovascular repair of the transplanted renal artery anastomotic pseudoaneurysm using the snorkel technique.From april 2012 to december 2017, we performed endovascular repair in six patients, who were diagnosed with transplanted renal artery anastomotic pseudoaneurysm, using the snorkel technique.The ¿snorkel¿ stent and the ¿parallel¿ stent were placed in the transplanted kidney and the external iliac artery, respectively.Another covered stent was implanted at the proximal end of the external iliac artery to match the diameter of the iliac artery.In the first patient, fluency stents were used, and in the remaining five patients, viabahn stents (gore, inc., flagstaff, arizona) were used.Reported results stated one patient (case no.5) developed stent thrombosis and renal failure four months after the surgery.Although the trunk and branches of the renal artery were restored through thrombolysis, the transplanted kidney was not rescued due to the extensive obstruction of small blood vessels in the renal parenchyma (figure 3).Nephrectomy was subsequently performed.The stents were removed, and the iliac artery was repaired during the operation.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS
• Type of Device: ENDOVASCULAR GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: pixie xi ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10354730
• MDR Text Key: 201682527
• Report Number: 2017233-2020-01072
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/03/2020

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: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 08/03/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR