MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT II EXTENSION CUFF; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	ETEW2020C82E
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	03/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Off-label, unapproved or contraindicated use (not implanting a bifurcated system).
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment the pre-operative rupture of an aortic fistula.It was noted that the aorto-gastric fistula was spitting up blood and this was a palliative procedure to prevent aortic rupture.It was reported that, during the index procedure, the physician asked that the patient not be intubated until after femoral access was gained.However, anesthesia did not wait and pressure dropped upon intubation.Percutaneous access was gained and a 12fr sheath was inserted.A reliant balloon was inserted and inflated.The physician stated that they would have preferred to remove the balloon prior to deployment of the stent graft, but thought that the patient may bleed out.The stent graft was deployed and pressure stabilized.During removal of the balloon, the balloon caught on the proximal edge of the stent graft and partially folded it back on itself.Imaging was done and determined there was no damage.It was noted the stent graft was ballooned and the rupture was sealed, resolving the event.No additional clinical sequelae were reported and it was noted that the patient would be going home to wait out the final days of unrelated end stage bladder cancer.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II EXTENSION CUFF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6499047
• Report Number: 2953200-2017-00617
• Device Sequence Number: 10914128
• Product Code: MIH
• UDI-Device Identifier: 00613994991393
• UDI-Public: 00613994991393
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2018
• Device Model Number: ETEW2020C82E
• Device Catalogue Number: ETEW2020C82E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/28/2017
• Supplement Date Received by Manufacturer: 03/28/2017
• Initial Report FDA Received Date: 04/17/2017
• Supplement Report FDA Received Date: 10/17/2017
• 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: Life Threatening; Required Intervention
• Patient Age: 65 YR