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

Model Number	SENSH2228W
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	Stroke/CVA (1770); Perforation of Vessels (2135)
Date of Event	10/05/2017
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
A senrant sheath was conduit for a valiant stent graft system used for the endovascular treatment of a 60 mm in diameter thoracic aortic aneurysm.It was reported that some difficulties were encountered during the advancement of the sentrant sheath and in gaining access to the common iliac artery.Per the physician the cause of the insertion difficulties was anatomy related, due to tissue degradation and vessel diameter.It was also reported that post index procedure but on the same day, a ruptured iliac artery was discovered.The physician implanted another manufacturer¿s self-expanding stents, and covered stents to exclude the vessel rupture.Post index procedure the patient also suffered a cva/stroke.As per the physician, the cause of the stroke cannot be determined.No additional clinical sequelae were reported and the patient will be monitored by the physician.
Additional Manufacturer Narrative
Films review summary: the exact cause of the difficulties reported during the advancement of the sheath to the common iliac artery and resulting iliac artery perforation could not be determined from the pre-implant films provided.Films during implant showing the event were not available, pre-implant ct¿s returned did not show below a short (3cm) length segment of the external iliacs, and post-implant films showing the stent graft in-vivo configuration could not be assessed.The patient had an 61mm maximum diameter aneurysm in the descending thoracic and a previous ascending thoracic repair.The distal aortic diameter was 22mm and calcified, and the iliac arteries were non-tortuous but extensively calcified bilaterally.The rcia flow lumen diameter ranged from 8 ¿ 7mm, the lcia diameter ranged from 10 ¿ 13 mm, and the external iliacs were 7 ¿ 7.5mm in diameter and calcified in the ~3cm viewable length.It appears likely that the patient¿s anatomy, calcified/small access vessels, likely contributed to the positioning difficulties and iliac artery perforation.The cause of the stroke could not be determined.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SENTRANT INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• MDR Report Key: 6995636
• Report Number: 2953200-2017-01681
• Device Sequence Number: 16466839
• Product Code: DYB
• UDI-Device Identifier: 00643169150355
• UDI-Public: 00643169150355
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 11/28/2017

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: 06/09/2018
• Device Model Number: SENSH2228W
• Device Catalogue Number: SENSH2228W
• Device Lot Number: 00124108
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2017
• Supplement Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 11/02/2017
• Supplement Report FDA Received Date: 11/28/2017
• 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: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 62