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

Catalog Number HT070080

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Thrombosis/Thrombus (4440)

Event Date 08/14/2015

Event Type  Injury  

Event Description

The following was reported to gore: on (b)(6) 2015, the patient presented with ischemic rest pain (rutherford 4, fontain iii) because of an occlusion of the high popliteal artery due to occlusive peripheral arterial disease (pad).Reportedly, the patient had previous endovascular treatment of an aneurysm of the right popliteal artery that was excluded with a stent (not further specified).Furthermore the patient history included thrombolysis on the right popliteal artery.On (b)(6) 2015, the patient underwent open surgical treatment for an occlusion of the popliteal artery.The lesion was bypassed with a gore® propaten® vascular graft.The distal anastomosis was below the knee, the proximal anastomosis was at the high popliteal artery.The device was implanted and retained successfully and there were no adverse events during the procedure.The patient recovered uneventful and was discharged home on (b)(6) 2015.Reportedly, on (b)(6) 2015, a hematoma (origin no further specified) has developed at the proximal and the distal anastomoses of the vascular graft requiring treatment.On (b)(6) 2015, the hematoma was evacuated.The patient recovered without sequelae.

Manufacturer Narrative

Evaluation codes investigation findings c19 belongs to the product history review: a review of the manufacturing records indicated the lots met all pre-release specifications (manufacturing).Evaluation codes type of investigation b13: additional information in regard to the event of the case was requested from the physician.The provided additional information is captured in the event.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

The following was reported to gore: on (b)(6) 2015, the patient presented with ischemic rest pain (rutherford 4, fontain iii) because of an occlusion of the high popliteal artery due to occlusive peripheral arterial disease (pad).Reportedly, the patient had previous endovascular treatment of an aneurysm of the right popliteal artery that was excluded with a stent (not further specified).Furthermore the patient history included thrombolysis on the right popliteal artery.On (b)(6) 2015, the patient underwent open surgical treatment for an occlusion of the popliteal artery.The lesion was bypassed with a gore® propaten® vascular graft.The distal anastomosis was below the knee, the proximal anastomosis was at the high popliteal artery.The device was implanted and retained successfully and there were no adverse events during the procedure.The patient recovered uneventful and was discharged home on (b)(6) 2015.Reportedly, on (b)(6) 2015, a hematoma (origin no further specified) has developed at the proximal and the distal anastomoses of the vascular graft requiring treatment.On (b)(6) 2015, the hematoma was evacuated.The patient recovered without sequelae.

Manufacturer Narrative

H6: code d12: the instructions for use (ifu) for the gore® propaten® vascular graft for the applicable region and time period was reviewed, and the following ifu statements were identified: adverse events: potential device or procedure-related adverse events.Adverse events which may require intervention and/or conversion to open repair include, but are not limited to: ¿ perigraft hematomas.H1/2: added information to the event description.Cause investigation and conclusion: additional information to the event and patient information have been requested from the study coordinator.The answers are captured in the event description.A review of the manufacturing records indicated the lots met all pre-release specifications.The device remains implanted in the patient.Therefore, a device evaluation could not be performed.The risk management documents for the gore® propaten® vascular graft were reviewed.No potential new or different reasonably foreseeable risk related to the device or its use were identified based on this event.The benefit of the product has been assessed against the overall residual risk and determined that the benefit of the product outweighs the risk to the patient.Ongoing risk/benefit assessment and acceptability of residual risk serves to reaffirm risk acceptability based on current performance.No corrective measures are needed as a result of this event.Gore monitors complaints closely to ensure that risks remain within the bounds estimated in the risk management documents.With the information reported to gore this investigation is considered complete, the cause of the complaint was unable to be determined.Based on the event description and the subsequent investigation, no further information was provided to gore, therefore we are unable to determine the cause of this incident and assign a root cause.Considering the nature of this event and the results of this investigation, this occurrence did not warrant remedial, corrective or preventative action in addition to no field safety action.

• Brand Name: GORE® PROPATEN® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• 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: kerstin haberlaender ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16311719
• MDR Text Key: 308938045
• Report Number: 2017233-2023-03692
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2019
• Device Catalogue Number: HT070080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2015
• 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; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male