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

Device Problems Material Rupture (1546); Device Damaged by Another Device (2915)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/27/2021

Event Type  Injury  

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium apl, which in covalently bound to the device surface and is essentially|non-eluting.

Event Description

The following information was reported to gore: on an unknown date, this patient underwent left forearm - upper arm av shunt surgery using gore® propaten® vascular graft for renal failure.On (b)(6) 2021, the patient underwent percutaneous transluminal angioplasty to remove thrombus of the device.It was reported that the device ruptured when the device was dilated using 7mm balloon.The ruptured part and a few centimeters from ruptured part was explanted.The physician stated that the 5mm propaten ruptured when it was dilated using 7mm balloon.That part was frequently punctured part.

Manufacturer Narrative

D4 - serial number updated.D8 / d9 - device available for evaluation, yes.H6 - component code, 525 (tube) updated.H6 - type of investigation, 3331 (analysis of production records) updated.H6 - type of investigation, 10 (testing of actual/suspected device) updated.H6 - investigation findings, 213 (no device problem found) updated.H6 - investigation findings, 213 (no device problem found) updated.A review of the manufacturing records indicated the lot met pre-release manufacturing specifications.Explant evaluation summary: the device fragment was returned to w.L.Gore & associates for investigation.Submitted in formalin was a gore propaten vascular graft fragment (vgf) with an attached (via anastomosis) gore acuseal vascular graft fragment.Two tissue specimens were collected and subjected to histopathological analysis.Microscopically, the sections examined had thick layers of collagenous neointima within the lumen.Embedded in the abluminal tissues were multiple plaques of osteoid like material, consistent with osseous metaplasia, which was partially mineralized.The eptfe vascular graft wall was microscopically normal and had collagen filled tracts (cannulation sites, presumptive).There was no evidence of inflammation.The lumen loss by neointima and osseous metaplasia in the abluminal tissues would be expected in a long-term vascular access graft implant in a patient undergoing dialysis.The disruption was consistent with an area that had been subjected to severe, concentrated cannulations with accompanied technique (i.E., shallow-angle cannulations, cannulation in proximity to anastomosis, cannulation of the same area/repeated cannulation) and then ballooned with too large of a ballooning device (7 mm balloon) in a 5 mm (inner diameter) device.Engineering evaluation: the provided images appear to depict a propaten® blue line pattern.The provided images appear consistent with the case description but could not be confirmed.The evaluation found no anomalies attributable to the manufacture of the device.The gore® propaten® vascular graft instructions for use (ifu), for the appropriate region and time-period, was reviewed with respect to the complaint detail and there are applicable statements.The ifu provides instruction the patients should be carefully monitored when using gore tex® vascular grafts for vascular access.Puncture sites must be adequately separated when repeated needle punctures of the graft are necessary.Multiple punctures in the same area may lead to disruption of the graft material or formation of a perigraft hematoma or pseudoaneurysm.

Manufacturer Narrative

B1: adverse event selection corrected.

• Brand Name: GORE® PROPATEN® 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 ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11286379
• MDR Text Key: 230627604
• Report Number: 2017233-2021-01651
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K062161
• 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,Followup
• Report Date: 05/12/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 04/05/2022; 05/12/2022
• Supplement Dates FDA Received: 04/05/2022; 05/12/2022
• 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; Other