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

Catalog Number	PXB35-06-57-080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	09/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The visi-pro balloon-expandable biliary stent system from the implant procedure was not received for evaluation.No cine images from either the implant, post/follow-up, or explant procedure were received for evaluation.From the explant procedure a portion of the visi-pro balloon-expandable stent was received entangled within the gold/tungsten hoop of a snare.Based on the radiopaque marker hoops and stent strut pattern, the returned stent segment is from a visi-pro stent.The returned stent segment is approximately 25mm in length.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient had an x-ray for an unrelated issue; it was observed on the x-ray that a previously implanted visi-pro stent in the left upper extremity venous system was fractured, procedure completed by dr (b)(6) ((b)(6) 2018).The visi-pro had been implanted to treat a fibrous lesion which was pre-dilated using a 4x80 balloon.The visi-pro was implanted in the left proximal to treat a fibrous lesion, artery diameter 6mm the lesion was pre-dilated using a 4x80 balloon.The x-ray showed a portion of the stent had migrated to the left pulmonary artery.The physician removed the fractured stent using a snare, pulling the fractured portion into the sheath and removing as a unit by dr (b)(6) ((b)(6) 2018).No injury to the patient reported.
Additional Manufacturer Narrative
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: 7973594
• Report Number: 2183870-2018-00470
• Device Sequence Number: 1254980
• Product Code: FGE
• UDI-Device Identifier: 00821684036358
• UDI-Public: 00821684036358
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/06/2019

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: 03/10/2019
• Device Catalogue Number: PXB35-06-57-080
• Device Lot Number: A240962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 03/06/2019
• 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: 50 YR