MAUDE Adverse Event Report: MEDTRONIC CARDIOVASCULAR SENTRANT INTRODUCER SHEATH; INTRODUCER, CATHETER

Model Number	SENSH1628W
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Perforation of Vessels (2135)
Date of Event	09/05/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 5.4 cm abdominal aortic aneurysm.It was reported the main body was placed on the right side.A 16 fr sentrant sheath was then inserted on the left to maintain access for gate cannulation for the contralateral limb.The physician then reportedly pulled the sheath back and lost access in the tortuous iliac artery.They then attempted to insert the sheath with a stiff wire in place, but the iliac artery became perforated and the patient became unstable.They finished placing the ipsilateral side of the main body and placed a reliant balloon above the celiac artery to stabilize blood pressure.The physician then opted to perform an open conversion and the physician left the sheath in the iliac artery until the proximal repair was completed.The stent graft was partially explanted and an aorto-bifemoral bypass graft was sewn in and tied to the femoral arteries bilaterally.This reportedly resolved the event at the time; however, the patient expired later that evening from compartment syndrome.The physician stated that the cause of the event was due to patient anatomy; specifically, tortuosity of the iliac arteries which created difficulty in accessing the aorta on the contralateral side.No additional clinical sequelae were reported.

• Brand Name: SENTRANT INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC CARDIOVASCULAR; 3576 unocal pl; santa rosa CA 95403
• MDR Report Key: 6899927
• Report Number: 2953200-2017-01506
• Device Sequence Number: 482558
• Product Code: DYB
• UDI-Device Identifier: 00643169150324
• UDI-Public: 00643169150324
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K123990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/05/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2018
• Device Model Number: SENSH1628W
• Device Catalogue Number: SENSH1628W
• Device Lot Number: 00124103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 09/28/2017
• 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: Death
• Patient Age: 72 YR