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

Model Number	SENSH2028W
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	06/19/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant aui stent graft system was implanted in a patient for the endovascular treatment of a 53x52mm diameter abdominal aortic aneurysm utilizing a sentrant sheath.The proximal left external iliac artery was 6mm in diameter.The proximal aortic neck measured 29 mm to 31 mm in diameter along a 10 mm length.It was reported that the right common femoral artery was exposed and controlled with vessel loops.The artery was accessed with an 18g needle and wires and catheters were used to gain access into the aorta.The physician placed a 20fr sheath over a lunderquist wire into the infrarenal aorta.Once the sheath was in place the endurant aui was prepped.The physician accessed the sheath with a wire and pig tail catheter.An aortogram was performed and the renal arteries were identified.The pig tail catheter was removed and replaced with the aui.The aui was placed was below the renal arteries with no issues.The 20fr sheath was pulled distal to the hypogastric and an angiogram done to mark the location of the left common iliac artery.An endurant limb was placed in proper position.The aui and limb were ballooned with a reliant with no issue.At this time the patient started having blood pressure issues.The physician performed an angiogram though the 20fr sheath showing that the proximal left external iliac artery has been ruptured.The physician then extended the limb with an endurant limb stent graft covering the rupture point and ballooned with the reliant.The physician left the reliant up for roughly 1-2minutes.The reliant was replaced with a pig tail catheter.An angiogram of the proximal edge of the graft showed that there was no proximal type i endoleak and the proximal edge was in good position distal to the renal arteries.An angiogram of the limb showed that the rupture site had sealed.The physician placed 4 endoanchors in the proximal edge of the stent graft.All of the devices were removed and the patients left common femoral vein graft was replaced/repaired with another graft.The patient did not have any other bleeding or blood pressure issues.Per the physician the cause of the event was anatomy related (6mm diameter proximal left external iliac artery).No additional clinical sequelae were reported 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
• MDR Report Key: 6704385
• Report Number: 2953200-2017-01113
• Device Sequence Number: 13673524
• Product Code: DYB
• UDI-Device Identifier: 00643169150348
• UDI-Public: 00643169150348
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/19/2017

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: No Information
• Device Expiration Date: 07/08/2017
• Device Model Number: SENSH2028W
• Device Catalogue Number: SENSH2028W
• Device Lot Number: 00114416
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2017
• Initial Report FDA Received Date: 07/11/2017
• 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: Required Intervention
• Patient Age: 64 YR