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

Catalog Number	PXB35-10-27-135
Medical Device Problem Codes	Premature Activation (1484); Malposition of Device (2616)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/07/2018
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
Patient came in for a fu cerebral angiogram as an outpatient.It is reported there was an unsuccessful stent deployment in the right subclavian artery with subsequent migration and deployment in the right internal iliac artrey after the stent detached prematurely.Attempts were made.The stent remains patent.No evidence of flow limitation to the internal iliac artery and its distal branches.The procedure was completed otherwise without issue.
Additional Manufacturer Narrative
Additional information: there was no pre-dilation done before stent was advanced into the right subclavian.There were 2 unsuccessful attempts to place the stent but it did not advance.The physician then used an evercross 5x40 to pre dilate.The physician then tried delivering stent once again but could not.After a third unsuccessful attempt he saw that the stent came off the balloon and remained in the body in the right iliac.The physician then tried to snare the stent but was unsuccessful.The physician felt that stent did not obstruct flow to the right iliac.The stent remains in patent.The patient is stable & is doing well.The physician who carried out the procedure was dr.(b)(6) if information is provided in the future, a supplemental report will be issued.
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: 7722644
• Report Number: 2183870-2018-00396
• Device Sequence Number: 18982664
• Product Code: FGE
• UDI-Device Identifier: 00821684036655
• UDI-Public: 00821684036655
• 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
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2018

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: 11/08/2020
• Device Catalogue Number: PXB35-10-27-135
• Device Lot Number: A553572
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 08/16/2018; 08/08/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 09/12/2018; 10/04/2018
• 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: 80 YR