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

Catalog Number	PXB35-07-37-135
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2018
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
The physician was attempting to use a visipro balloon expandable stent to treat a soft tissue lesion in the right distal common iliac artery.The lesion was not calcified, had no stenosis and was not tortuous.The artery diameter was 7-8mm.The device was prepped as per the ifu with no issues identified.The vessel was not pre-dilated and no excessive force was used.The device did not pass through a previously deployed stent.There was sufficient distal landing zone.During the advancement of the device to the intended lesion site the proximal portion of the stent deployed, the visipro was inflated and deployed in the external iliac artery.No attempts were made to remove the stent.The procedure was completed with alternate balloon expandable stents deployed to bilateral common iliac stents successfully.No patient injury was reported.

• 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: 7357400
• Report Number: 2183870-2018-00168
• Device Sequence Number: 16419809
• Product Code: FGE
• UDI-Device Identifier: 00821684036433
• UDI-Public: 00821684036433
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/21/2018

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: 07/20/2020
• Device Catalogue Number: PXB35-07-37-135
• Device Lot Number: A495822
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 03/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 107