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

Catalog Number	PXB35-05-17-080
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Occlusion (1984); Patient Problem/Medical Problem (2688)
Date of Event	10/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The visi-pro balloon-expandable biliary stent system was not received for evaluation.No ancillary devices from the procedure were received.Three cines images from the procedure were received for evaluation.The first image was of a support catheter at the targeted vessel anatomy.The second image was of a snare attempting to snare the dislodged visi-pro stent; a couple of the stent radiopaque marker hoops were seen bent out of position.The third image was of the snared dislodged visi-pro stent being pulled towards the support catheter; radiopaque marker hoops were bent out of position at both ends of the stent.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician was attempting to use a visi pro device to treat a moderately calcified lesion with 95-99% stenosis in the right mid distal iliac and renal arteries.Artery length and lesion diameter were 5mm and 17mm.The physician used a 6fr non-medtronic 45cm sheath and a 0.035 non-medtronic guidewire.The ifu was followed and the device was prepped without issue.No pre-dilation was performed prior to attempting to cross the lesion.The physician reported excessive force was used during advancement and delivery of the device to its desired location.It was reported that the stent dislodged in an unintended lesion.Stent was partially snared and was deformed during snare attempts.The stent then became lodged in the right iliac artery.Physician was unable to remove the stent through the sheath.The dislodged stent was removed in the or by open surgery.The patient incurred vessel occlusion and a retroperitoneal haemorrhage due to the surgery to remove the stent.
Additional Manufacturer Narrative
Evaluation summary: the visi-pro balloon-expandable biliary stent system was received for evaluation.The visi-pro balloon expandable stent was not returned.The balloon chamber of the visi-pro balloon expandable stent delivery system was in a pre-inflation profile.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: 8046319
• Report Number: 2183870-2018-00501
• Device Sequence Number: 1464001
• Product Code: FGE
• UDI-Device Identifier: 00821684036204
• UDI-Public: 00821684036204
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2018

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: 10/27/2019
• Device Catalogue Number: PXB35-05-17-080
• Device Lot Number: A366398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 12/14/2018
• 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: 77 YR
• Patient Weight: 72