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

Catalog Number HT066070

Device Problems Obstruction of Flow (2423); Material Split, Cut or Torn (4008)

Patient Problem Obstruction/Occlusion (2422)

Event Date 01/16/2022

Event Type  Injury  

Manufacturer Narrative

A part of the graft was explanted, returned and will be further investigated.The investigation has not yet begun.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

It was reported to gore that on (b)(6) 2022, the patient required a thrombectomy of an occluded crural bypass which was performed on (b)(6) 2022 with a gore® propaten® vascular graft to treat a peripheral artery disease (artery occlusion).The thrombectomy required an incision into the gore® propaten® vascular graft.It was stated that when the thrombectomy was performed and the graft intended to be closed by sewing (graft - graft) the vascular graft material tore out several times when the thread was pulled through the graft.It was re-sewn several times and finally the surgery could be finished successfully with a patent bypass.Following the procedure, it was noticed that the peripheral outflow was not satisfying in the anterior tibialis artery.It was stated that on (b)(6) 2022 the lower leg was amputated due to a minor perfusion.It was reported that the physician stated that the amputation of the lower leg was not associated with the implanted gore® propaten® vascular graft.

Manufacturer Narrative

Explant investigation: summary of findings: the graft fragment was returned to w.L.Gore & associates for investigation.Submitted in formalin was a gore® propaten® vascular graft fragment which had been transected prior to arrival at w.L.Gore and associates.The returned fragment presented in a c-shaped flattened configuration with two bent (folded) regions and multiple displaced abluminal rings.The ablumen was generally devoid of tissue.One end had a section of light tan/brown tissue anastomosed to the graft with multiple sizes of blue monofilament suture.Evenly spaced serration marks were also visible on the ablumen of the graft.There was a blue monofilament single suture knot, and a cluster of different sizes blue monofilament sutures visible on the abluminal surface.The cluster site resulted in flattened and undulating graft material.Numerous cuts were present in both the graft and the rings adjacent to this site consistent with suture needle disruptions.Luminal patency was not determined due to the folded nature of the anastomosed tissue.Histopathological examination was not performed due to the lack of adherend tissue and the nature of the complaint.The graft was subjected to an enzymatic digestion process to remove biologic debris.Following digestion all graft was examined for material disruptions with the aid of a stereomicroscope and regionally imaged using scanning electron microscopy (sem).Disruptions identified were not associated with handling or manufacturing process at w.L.Gore & associates.The disruptions were consistent with a manual manipulation via surgical instrumentation (e.G., hemostats, scalpel, scissors) likely used during a surgical procedure.There were tears in the graft material consistent with suture pull through noted in an area where the radial film had been displaced (presumed access site of reported intervention procedure).The helically wrapped radial film was present on the graft fragment with the exception of intermittent presence at the ¿access site¿.The displacement of the radial film was likely a result of graft manipulation during the intervention procedure.The loss of the radial film would reduce suture retention.Additionally, the procedure details (e.G., suture needle type, access details, handling) were not provided and may have also impacted suture retention.

Manufacturer Narrative

C1 was updated: cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.B4 and b7: updated / additional information.

Event Description

On (b)(6), 2022, a gore® propaten® vascular graft was implanted in the patient's lower leg, from the femoral artery to anterior tibial artery, to treat a peripheral artery disease (artery occlusion).On (b)(6) 2022, the patient required a thrombectomy due to occluded crural bypass.The thrombectomy required an incision into the gore® propaten® vascular graft.During the intervention, the graft was cut in half in order to gain access to the thrombus.After the thrombectomy, when the vascular graft was being sewn closed (graft - graft) the vascular graft material tore out several times as the suture was pulled.The vascular graft required multiple stitches and finally the procedure was finished with a patent bypass.Following the procedure, it was noted that the peripheral outflow to the anterior tibialis artery was not satisfactory.On (b)(6) 2022, the lower leg was amputated due to a lack of perfusion.The physician stated the amputation of the lower leg was not associated with the implanted gore® propaten® vascular graft.The patient already had poor circulation and poor drainage.

• 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 WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13531963
• MDR Text Key: 286961268
• Report Number: 2017233-2022-02744
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HT066070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2021
• 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: 72 YR
• Patient Sex: Female