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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM; CATHETER, BILIARY, DIAGNOSTIC
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COVIDIEN VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Catalog Number PXB35-09-37-135
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Death (1802)
Date of Event 08/02/2017
Type of Reportable Event Death
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.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 to treat an unknown lesion.It was reported that 5 days later, the patient expired.
 
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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 Key6927332
Report Number2183870-2017-00434
Device Sequence Number13748466
Product Code FGE
UDI-Device Identifier00821684036594
UDI-Public00821684036594
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K061566
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Operator of Device Health Professional
Device Expiration Date06/13/2020
Device Catalogue NumberPXB35-09-37-135
Device Lot NumberA475451
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/08/2017
Initial Report FDA Received Date10/07/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Death;
Patient Age68 YR
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