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

Model Number	26280
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the stent was returned partially deployed on the delivery system.The investigator successfully deployed the stent with slight resistance due to the presence of solidified blood on the delivery system.A visual and microscopic examination identified damage to the distal stent wires.This type of damage is consistent with the stent encountering resistance during the attempt to deploy.A visual and microscopic examination identified no damage or issues with the stent cups or stent holder of the returned device.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 returned device.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 22-jan-2019.It was reported that the stent failed to deploy.The 70% stenosed target lesion was located in the non tortuous and non calcified left iliac vein.A 16x90/9fr uni plus 75cm wallstent endoprosthesis stent was advanced to treat the lesion; however, the stent failed to deploy.The procedure was completed with another of the same device.No patient harm nor complications were reported and the patient's status was fine.However, device analysis revealed damage to distal stent wires.

• 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: 8326285
• Report Number: 2134265-2019-01000
• Device Sequence Number: 2254316
• Product Code: MAF
• UDI-Device Identifier: 08714729204053
• UDI-Public: 08714729204053
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 02/11/2019

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: 10/09/2020
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0022771402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR