MAUDE Adverse Event Report: COVIDIEN VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM; CATHETER, BILIARY, DIAGNOSTIC

Catalog Number	PXB35-09-57-135
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/26/2019
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
It was reported that a physician was attempting to use a visi pro stent system to treat a fibrous lesion in the mid right fistula exhibiting severe tortuosity and little calcification with 90% stenosis.No damage noted to packaging (i.E.Shelf carton, hoop/tray), no issues noted when removing the device from the hoop/tray, device was prepped per the ifu with no issues noted.It was reported that inaccurate delivery (i.E.Stent deployed in unintended lesion site) occurred.There was sufficient distal landing zone, the lesion was not pre-dilated or post dilated.The device did not pass through a previously-deployed stent, resistance was encountered when advancing the device, excessive force was not used.The procedure was completed by using a magic torque wire for intervention.Stent was not advancing through fistula so attempted to bring stent back into the sheath.At that point, the stent came off the balloon.The ends were already frayed out so the physician was unable to push stent into place.Deployed stent with 4mm, 6mm, and 12mm balloons.No further patient injury reported for this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8381383
• Report Number: 2183870-2019-00104
• Device Sequence Number: 1253096
• Product Code: FGE
• UDI-Device Identifier: 00821684036617
• UDI-Public: 00821684036617
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P030045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2019

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: 03/19/2021
• Device Catalogue Number: PXB35-09-57-135
• Device Lot Number: A615506
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 06/20/2019
• 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: 56 YR
• Patient Weight: 84