MAUDE Adverse Event Report: COVIDIEN VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM; STENT, ILIAC

Catalog Number	PXB35-07-57-135
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	09/19/2019
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 visi pro stent was used during treatment of a 30mm calcified lesion in the patient¿s proximal left common iliac artery of diameter 7mm.Moderate vessel tortuosity and calcification are reported.Lesion exhibited 40% stenosis.Ifu was followed and the device was prepped without issue.Pre-dilation was performed using a 6 mm pre-dilation device.The device was passed through a previously deployed stent, but no resistance was encountered.Patient was scheduled for re-intervention due to rest pain where it was discovered that the previously deployed stent had a complete fracture.Approximately 30 mm of the stent separated and drifted into the distal aorta.The remainder of the stent remained in the left common artery.It has not been confirmed if the fracture occurred at time of procedure or was already separated prior to angiogram.There were repeat interventions completed after and it appeared that the stent might have been compromised beforehand but uncertain.The separated stent was noticed on angiogram approximately 1 year post procedure.It was reported the physician tried to rewire stent in distal aorta and get balloon inside stent to pull back in left common iliac.This was unsuccessful and will be attempted at a later date.
Additional Manufacturer Narrative
Cine review: the customer provided 3 cine images each cine was able to show two implanted stents.The struts of each stent was visible.Tantalum markers of the ends of each stent were identified.The second cine image provided showed an off-set stent strut but could not conclusively identify a fracture to any of the stent struts.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information no intervention carried out at time fracture was observed.The detached portion remains in the patient¿s distal aorta.The physician has decided not to intervene as it is not expected to cause any injury.Patient is not experiencing any issues.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 9103708
• Report Number: 2183870-2019-00458
• Device Sequence Number: 2430589
• Product Code: NIO
• UDI-Device Identifier: 00821684036457
• UDI-Public: 00821684036457
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P030045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2019

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: 03/14/2021
• Device Catalogue Number: PXB35-07-57-135
• Device Lot Number: A613246
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 09/23/2019; 11/27/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 09/30/2019; 11/28/2019
• 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: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 51