MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE PROPATEN VASCULAR GRAFT (STRETCH REMOVABLE RING); PROSTHESIS, VASCULAR GRAFT

Catalog Number	HT083040A
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Codes	Stroke/CVA (1770); Death (1802); Occlusion (1984)
Date of Event	07/27/2018
Type of Reportable Event	Death
Event or Problem Description
The following was reported to gore: on (b)(6) 2018, a patient with a history of cabg x 4, cardiac stents x 3 presented with acute onset of chest pain, shortness of breath and generalized weakness.Patient was given nitroglycerin and she became unresponsive with seizure-like activity.Due to the nature of acute type, a dissection and risk of rupture, it was decided to not pursue emergent open repair given high risks of procedure.Patient was admitted for aggressive blood pressure and pain management.Over the next few days, the vascular surgery team decided to repair via endovascular approach.On (b)(6) 2018, the patient required 2u prbcs for anemia with concern for rupture due to hematemesis and melena.Patient underwent debranching with patent right common carotid to left subclavian artery graft with the left common carotid jump graft connection to this graft.As reported, an 8mm gore® propaten® vascular graft (thin walled removable ringed) was implanted during this procedure.In addition, thoracic aortic repair, stent graft placement in the innominate artery and implantation of a temporary transvenous pacemaker were performed.Egd (esophagogastroduodenoscopy) was completed post-op without ability to identify a source of bleeding.No active arterial extravasation or embolization were performed.On (b)(6) egd was repeated which again visualized a large organized clot at the distal portion of the stomach, but no active source of bleeding.Other post-operative complications include thrombocytopenia.On (b)(6) patient became hypotensive with dark melanotic colostomy output.Patient underwent cta on (b)(6) which demonstrated interval graft thrombosis as well as bilateral ischemic strokes and persistent gi bleeding.It was found the graft was occluded with thrombus.Graft thrombectomy was not considered due to ongoing contraindications to anticoagulation.Given patient's overall poor prognosis with minimal likelihood of meaningful recovery, care was withdrawn.Comfort care was provided and patient expired on (b)(6) 2018.As reported, cause of death is type a aortic dissection, gastric bleeding and stroke (thrombosis of carotid-subclavian bypass).Autopsy was not performed.

• Brand Name: GORE PROPATEN VASCULAR GRAFT (STRETCH REMOVABLE RING)
• Common Device Name: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7831061
• Report Number: 2017233-2018-00524
• Device Sequence Number: 19154303
• Product Code: DSY
• UDI-Device Identifier: 00733132606801
• UDI-Public: 00733132606801
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K062161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/31/2018

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: 04/06/2022
• Device Catalogue Number: HT083040A
• Device Lot Number: 5909690PP014
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 73 YR
• Patient Weight: 68