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

Catalog Number	PXB35-07-37-135
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2019
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 visipro stent to treat a lesion in the iliac artery ¿ common in a patient with moderate calcification and tortuosity and 80% stenosis.A non-medtronic 6frx45cm (terumo) sheath and.014x 300 (halberd) wire were also used.No damage noted to packaging noted, no issues noted when removing the device from the hoop/tray, device was prepped as per ifu.Resistance was encountered when advancing the device but no excessive force was required.It was reported that the stent dislodged during delivery to/at lesion; the visipro was inflated with a nanocross after it came off the balloon.A non-medtronic guide catheter was used to push stent down into position.This was then followed by another nanocross, and an evercross to expand the stent.Implanted another visipro at the lesion site.No further patient injury reported for this event.
Additional Manufacturer Narrative
Additional information received: use of the second visi-pro stent was planned.Visi-pro deployed at location where it dislodged from balloon.No allegation against either the nanocross or evercross balloons.Product analysis: the visi-pro balloon-expandable biliary stent system was received for evaluation.No ancillary devices or cine images from the procedure were received.The visi-pro was received without its stent and the balloon remained in pre-inflation profile, tightly wrapped or winged with stent crimp witness marks.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: 8361712
• Report Number: 2183870-2019-00088
• Device Sequence Number: 16648599
• Product Code: FGE
• UDI-Device Identifier: 00643169787803
• UDI-Public: 00643169787803
• 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): 03/19/2019

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: 12/20/2021
• Device Catalogue Number: PXB35-07-37-135
• Device Lot Number: A758972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 03/19/2019
• 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: 66 YR
• Patient Weight: 78