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

Catalog Number HT084050

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Blood Loss (2597); No Information (3190); Multiple Organ Failure (3261)

Event Date 11/12/2018

Event Type  Death  

Event Description

The patient presented with femoral artery disease which was intended to be treated with a gore® propaten® vascular graft which was used to perform a femoropopliteal bypass.It was reported to gore that the gore® propaten® vascular graft ¿broke¿ in the night after the procedure.The medical device was explanted.

Manufacturer Narrative

Additional information was entered into report.Patient death & date, update of event description, catalog#, expiration date, unique identifier (di)#, implant & explant date on (b)(6) 2019.Added method & result codes: method code 213: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.

Event Description

The patient presented with critical ischemia within the femoral artery which was intended to be treated with a gore® propaten® vascular graft which was used to perform a femoropopliteal bypass.It was reported to gore that the gore® propaten® vascular graft ¿broke¿ right at the anastomosis heel in the night after the procedure and that the patient bleed a lot.Consequently, the medical device was explanted.It was stated that the patient died due to multi-organ failure.

Manufacturer Narrative

Additional information was entered into report.B1:correction of date of event ¿ november 12, 2018.

Manufacturer Narrative

Our engineers have evaluated the returned device.Their investigation indicates the following: the device 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 lumen of the graft was patent.The graft fragment presented in a u shape with a v shaped cut out of material and focal full thickness perforations at pole 1, (referring to pole 1 as proximal end).Outer rings had been removed near the pole and adjacent intact rings had disruptions present.The free edge at pole 1 was generally rough in appearance.Pole 2 had a fragment of blue suture present under an outer graft ring all outer rings were present and the free edge was smooth and elliptical in shape.Along the ablumen of the graft was sparse multifocal deposits of friable red tan to black hemorrhagic material and three foci of white fat deposits were also adhered to the surface.The lumen of the graft had scant red brown material present near pole 1.Histopathological analysis was not performed due to the paucity of adherent tissue and the implant duration.The device fragment were subjected to an enzymatic digestion process to remove biologic debris.Following digestion the device fragment was examined for material disruptions with the aid of a stereomicroscope and a scanning electron microscope (sem).Multiple rows of evenly spaced serration marks were present on the abluminal surface near fragment poles.A number of proximal rings were compressed/ disrupted.Suture holes were present along the periphery of the v shape cut in pole 1, consistent with the heel of an anastomosis.The cross section of pole 1 appeared largely roughened with minimal radial film disruption along partial periphery, consistent with acute, material tearing.Disruptions identified were not associated with handling or manufacturing process at wl gore and associates.The graft transection (pole 2) and manual manipulation of the graft/ rings via surgical instrumentation are consistent with a surgical procedure.Characteristics of the circumferential graft tear are consistent with an acute tension event; time frame and contributing events, leading to graft tear, could not be determined from the information provided.

Manufacturer Narrative

Additional information was entered into report: h4: device manufacture date.Correction was made for h1: type of reportable event.

Manufacturer Narrative

Correction of conclusion code.W.L.Gore & associates cautions in the instructions for use that the correct graft length for each procedure must be carefully determined, taking into consideration the patient¿s body weight and posture, and the range of motions likely to be encountered across the anatomical area of the graft implantation.The graft should never be too short.Complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: mechanical disruption or tearing of the suture line, graft, and/or host vessel.

• Brand Name: GORE PROPATEN VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8145785
• MDR Text Key: 129762941
• Report Number: 2017233-2018-00749
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2022
• Device Catalogue Number: HT084050
• Device Lot Number: 5867860PP007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2018
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 81 YR