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

Catalog Number	PXB35-07-17-080
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician used a visi pro balloon expandable stent system with a 7fr non-medtronic sheath and 0.035 non-medtronic guidewire for treatment of a calcified 17mm, 60% stenosed lesion in the patient¿s proximal right common iliac artery.The vessel diameter was reported to be 7mm.Slight tortuosity and moderate calcification were reported.The ifu was followed during prep and the device was prepped without issue.The device was passed through a previously deployed stent.The lesion was not pre-dilated.No resistance was experienced nor excessive force used.An inflation device was used for balloon inflation.It was reported that the balloon burst immediately upon inflation (pressure unknown).No fragments of the balloon were reported to have embolised.The stent was post-dilated with a 7x40 evercross device to complete the procedure.There was no issue noted when retracting the stent delivery system.No patient injury was reported.
Additional Manufacturer Narrative
Evaluation summary: the visi-pro was returned for evaluation.No ancillary devices were included.The visi-pro was inspected.It was identified the stent was not loaded on the balloon.The balloon was in a post-inflated state.No damages or anomalies were observed to the balloon segment under microscope.A 0.035" guidewire was unable to be loaded into the catheter.The guidewire encountered a blockage within the catheter.The returned visi-pro was connected to an inflation device.It was inflated to 12 atm (rated burst pressure) and no leaks to the balloon were noted.The inflation pressure was increased to 14 atm and no indication of a leak was identified.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: 7999967
• Report Number: 2183870-2018-00481
• Device Sequence Number: 1190256
• Product Code: FGE
• UDI-Device Identifier: 00821684036389
• UDI-Public: 00821684036389
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K061566
• 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
• Report Date (Section B): 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2020
• Device Catalogue Number: PXB35-07-17-080
• Device Lot Number: A562005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 66