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

Model Number SBT1802D

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Aneurysm (1708)

Event Date 11/17/2016

Event Type  Injury  

Manufacturer Narrative

As patient identifier the study- including hospital- and patient number was used.As the device remains implanted, no further investigation of the device can be performed.Further details were requested from the study coordinator, but not provided yet.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) 2016, the patient underwent surgical treatment for a protheto-femoral bypass with a gore-tex® stretch vascular graft.During surgery, there was blood loss, which required a blood transfusion.On (b)(6) 2016, a revision of the protheto-femoral anastomosis was performed.The patient was admitted to the icu and discharged to a rehabilitation center on (b)(6) 2017.Further details were requested from the study coordinator, but not provided yet.

Manufacturer Narrative

H1 type of reportable event must be "other".Review of new provided information from the hospital changes this event to not-reportable per our regulatory reporting guidelines, as the physician stated that there isn¿t any allegation or malfunction against the gore-tex® stretch vascular graft and that the high amount of blood loss is not related to a malfunction against the device.Also the revision of the protheto-femoral anastomosis which was performed was not related to the gore-tex® stretch vascular graft.As there is no allegation of a serious injury or malfunction of the gore-tex® stretch vascular graft in question anymore, this event is considered not reportable.The report is being retracted.

Event Description

The following was reported to gore: on (b)(6) 2016, the patient underwent surgical treatment for an acute ischemia with thrombosis on the deep femoral artery.A gore-tex® stretch vascular graft was implanted as aorto bifemoral bypass.During surgery, there was blood loss, which required a blood transfusion.On (b)(6) 2016, a revision of the protheto-femoral anastomosis was performed.The patient was admitted to the icu and discharged to a rehabilitation center on (b)(6) 2017.The study coordinator stated that there isn¿t any allegation or malfunction against the gore-tex® stretch vascular graft and that the blood loss is not related to a malfunction of the device.

Manufacturer Narrative

B5: describe event or problem : according to received information from the study coordinator the event description was updated accordingly.Furthermore the study coordinator stated that there isn¿t any allegation or malfunction against the gore-tex® stretch vascular graft and that the blood loss is not related to a malfunction of the device.

• Brand Name: GORE-TEX® STRETCH 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15184704
• MDR Text Key: 297452699
• Report Number: 2017233-2022-03195
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132612062
• UDI-Public: 00733132612062
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K904282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: SBT1802D
• Device Catalogue Number: SBT1802D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2016
• 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: 76 YR
• Patient Sex: Male