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

Model Number	SENSH2228W
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Perforation of Vessels (2135); Blood Loss (2597)
Date of Event	03/08/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the reported right iliac artery been torn away during removal of the delivery system and sheath, leading to the reported blood pressure drop with uncontrolled bleeding, could not be determined from the pre-implant films provided.Images during implant were not available for return, and the reported event could not be assessed.Review of a pre-implant ct/3d film report revealed that the patient had a 58mm max diameter x 80mm length taa located near the top of the arch.The thoracic anatomy was not appreciably tortuous.The iliac arteries were non-tortuous with no appreciable calcification or thrombus seen bilaterally.The right common iliac diameter measured 7 ¿ 7.5mm, the left common iliac diameter measured 7.5mm, and the access vessels measured at the femoral head were of small caliber measuring 6.1mm on the right and 6.4mm on the left.It is possible that these events were user and/or anatomy related to the small caliber access and iliac vessels.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant navion stent graft system was implanted in a patient for the endovascular treatment of a 58 mm thoracic aortic aneurysm.A sentrant sheath was also used during the procedure to access the right iliac artery.The patient's external iliac arteries were 7 mm in diameter.No tortuosity or calcification of the access vessels was noted.It was reported that the navion device was placed through the sentrant sheath and advanced into the patient's descending thoracic aorta under fluoroscopy.The stent graft was deployed successfully, and the delivery system was retracted and removed from the patient via the sheath.Thereafter, the sentrant sheath was removed from the patient.When it was completely removed from the patient, the patient's tissue was observed to be connected to the sheath and it was reported that the patient's right iliac artery was avulsed.Following that observation, the patient's blood pressure significantly dropped and they experienced uncontrolled bleeding.The patient's blood pressure was controlled by repairing the anatomy, and they were transferred out of the operating room.The patient expired one day post procedure.As per the physician, the cause of the avulsion was user error.The physician believed that too much pressure was applied to the abdomen/site of the arteriotomy at the same time as the sheath was being removed from the patient.The cause of death is currently unknown.No additional clinical sequelae were reported.

• Brand Name: SENTRANT INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC CARDIOVASCULAR SANTA ROSA; 3576 unocal place; santa rosa CA 95403
• MDR Report Key: 8435600
• Report Number: 2953200-2019-00385
• Device Sequence Number: 1795170
• Product Code: DYB
• UDI-Device Identifier: 00643169792623
• UDI-Public: 00643169792623
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Followup
• Report Date (Section B): 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: SENSH2228W
• Device Catalogue Number: SENSH2228W
• Device Lot Number: 00134861
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/12/2019
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 06/11/2019
• 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; Required Intervention
• Patient Age: 71 YR