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

Model Number	SENSH1628W
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant iis bifurcate stent graft system was implanted in the endovascular treatment of a 53mm abdominal aortic aneurysm.A sentrant sheath was also used.The procedure was also focused on the revision of a previously implanted non mdt (afx) stent graft system.It was reported that percutaneous access was attempted but due to scar tissue from the first procedure access was difficult, the procedure then was converted to open repair.It was said it was challenging to place wires without entanglement inside the non mdt stent graft system.It was reported implanting the endurant iis stent graft system was uneventful and well placed.The procedure ran for 3.5 hours.The next day, unidentifiable post-operative bleeding occurred.The patient required an open exploratory surgery and also vacuum-assisted closure (vac) of the wound was needed.As per the physician the cause of the event could not be determined.The physician didn't suspect the sentrant or endurant devices played a role in causing the bleeding.However it was considered that the devices may have helped to hide the bleeding.  no additional clinical sequelae were provided and the patient is fine.

• Brand Name: SENTRANT INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway,ie ; EI
• MDR Report Key: 12337577
• Report Number: 9612164-2021-03186
• Device Sequence Number: 17278749
• Product Code: DYB
• UDI-Device Identifier: 00643169792593
• UDI-Public: 00643169792593
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K123990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2021

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: 04/07/2023
• Device Model Number: SENSH1628W
• Device Catalogue Number: SENSH1628W
• Device Lot Number: 00157732
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 08/18/2021
• 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: Other; Required Intervention
• Patient Age: 83 YR