MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	26280
Medical Device Problem Codes	Premature Activation (1484); Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that reconstrainment difficulties occurred.The target lesion wa located in the right common iliac vein.A 16x60/9fr wallstent uni was advanced for treatment along with a 18x90 wallstent in an attempt to barrel both stents into the inferior vena cava (ivc).However, it was noted that 20% of the 16x60 stent was deployed in the ivc.While attempting to recapture the stent for repositioning, the stent fully deployed.Another 18x90mm wallstent was deployed inside the stent and inflated with a 16x40mm xxl balloon catheter on both sides.No patient complications were reported and patient status was fine and stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned with the stent fully deployed.The stent was not returned for analysis.No damage or issues were identified with the stent cup or stent holder that could potentially have contributed to the complaint incident.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination identified no kinks or damage to the shaft of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that reconstrainment difficulties occurred.The target lesion wa located in the right common iliac vein.A 16x60/9fr wallstent uni was advanced for treatment along with a 18x90 wallstent in an attempt to barrel both stents into the inferior vena cava (ivc).However, it was noted that 20% of the 16x60 stent was deployed in the ivc.While attempting to recapture the stent for repositioning, the stent fully deployed.Another 18x90mm wallstent was deployed inside the stent and inflated with a 16x40mm xxl balloon catheter on both sides.No patient complications were reported and patient status was fine and stable.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9395936
• Report Number: 2134265-2019-14640
• Device Sequence Number: 1883350
• Product Code: MAF
• UDI-Device Identifier: 08714729204046
• UDI-Public: 08714729204046
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2020

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 Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0024329408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 04/06/2020
• 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: 62 YR