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

Model Number	26280
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the left common iliac vein.A 18x90/10fr uni plus 75cm wallstent endoprosthesis stent was advanced for treatment.However, during procedure, the stent was unable to cross over the wire once inserted into the sheath.The stent was successfully removed from the sheath undeployed and it was noticed that the tip of the stent had been pushed back into the stent catheter and the shaft was bent.The procedure was completed with a different device.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the left common iliac vein.A 18x90/10fr uni plus 75cm wallstent endoprosthesis stent was advanced for treatment.However, during procedure, the stent was unable to cross over the wire once inserted into the sheath.The stent was successfully removed from the sheath undeployed and it was noticed that the tip of the stent had been pushed back into the stent catheter and the shaft was bent.The procedure was completed with a different device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was received for analysis.The device was received with the stent over constrained and the tip withdrawn inside the blue outer sheath.For investigation purposes the investigator exposed the tip to facilitate loading the device on to a guidewire.This wallstent device is recommended for use with a 0.035 (0.89mm) guidewire as per wallstent.The guidewire used by the customer was not returned for analysis.During product analysis the investigator successfully inserted a boston scientific guidewire through this device with no resistance or issues experienced.The stent was returned in the correct position on the delivery system.The investigator successfully deployed the stent with some resistance experienced due to the presence of solidified media on the inside of the delivery system and stent.A visual and microscopic examination identified no issues or damage to the deployed stent.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 found the shaft of the returned device to be free from kinks or damage.No other issues were identified during the product analysis.

• 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: 10672071
• Report Number: 2134265-2020-14004
• Device Sequence Number: 19519026
• Product Code: JCT
• UDI-Device Identifier: 08714729204084
• UDI-Public: 08714729204084
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

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: 08/12/2022
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0025847136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1