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

Model Number	SB2201D
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Hypovolemic Shock (1917)
Date of Event	11/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The physician answered to the questions if images and/or the device are available with not applicable.As no device and no images are available, no further investigation can be conducted.Product history review: a review of the manufacturing records indicated the lots met all pre-release specifications.The physician stated that the observed complications are not attributable to our gore device.
Event or Problem Description
The following was reported to gore: on (b)(6) 2016, the patient underwent surgical treatment for infrarenal fusiform aortic aneurysm of 54 mm confirmed by cta with a gore-tex® vascular graft.During surgery, an intraoperative hemorrhagic shock occurred with blood loss of about 3.8 l, which required a blood transfusion.Bleeding persisted so the day after a revision surgery was performed allowing evacuation of a retroperitoneal hematoma.No active bleeding has been found.The patient was put in the icu and deceased 3 days later from refractory multiple organ failure.The physician stated that the observed complications are not attributable to our gore device.
Additional Manufacturer Narrative
According to the physician the gore device has not malfunctioned and the complications and/or adverse events observed as well as the later death are not attributable to our gore device.
Additional Manufacturer Narrative
H1 type of reportable event should be "other".Review of new provided information from the hospital changes this event to not-reportable per our surgical vascular graft worldwide reporting guidelines, when a blood transfusion is not attributable to the gore device.According to the physician the observed complications and the death are not attributable to our gore device.It was aortic state that caused that blood loss in this patient.The aorta appeared too damaged by disease, so per-operative bleeding could not be controlled.As there is no allegation of a serious injury or malfunction of the gore-tex® stretch vascular graft in question anymore per our worldwide reporting guidelines, this event is considered not reportable.Therefore the report is being retracted.

• Brand Name: GORE-TEX® STRETCH VASCULAR GRAFT
• Common Device Name: 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: 14673424
• Report Number: 2017233-2022-03007
• Device Sequence Number: 20182825
• Product Code: DSY
• UDI-Device Identifier: 00733132611881
• UDI-Public: 00733132611881
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K904282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/02/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/15/2019
• Device Model Number: SB2201D
• Device Catalogue Number: SB2201D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 10/17/2022; 12/27/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 11/07/2022; 01/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 69 YR
• Patient Sex: Male