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	Patient Problem/Medical Problem (2688)
Date of Event	02/25/2019
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 por stent system to treat a lesion in the prox iliac artery ¿ common exhibiting moderate calcification and tortuosity.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 stent dislodgement occurred during delivery to/at lesion.Stent was dislodged at the distal end of the sheath.Deployed a 4mm visi pro stent past the stent, inflated and pulled back the stent into the sheath.Pulled stent back through the sheath and successfully removed from the sheath.The device did not pass through a previously-deployed stent, resistance was not encountered when advancing the device, excessive force was not used.No further patient injury reported for this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
A 7fr terumo sheath was used to treat the lesion.The lesion was pre-dilated, resistance was encountered at the distal end of the sheath at the lesion site.It was reported that the physician thinks the stent dislodgement occurred due to the interaction with the sheath.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: 8381363
• Report Number: 2183870-2019-00103
• Device Sequence Number: 1922507
• Product Code: FGE
• UDI-Device Identifier: 00821684036617
• UDI-Public: 00821684036617
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P030045
• 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,Followup
• Report Date (Section B): 06/13/2019

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: 08/12/2021
• Device Catalogue Number: PXB35-09-57-135
• Device Lot Number: A691463
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 03/19/2019; 06/06/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 04/01/2019; 06/13/2019
• 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