MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT RP ENDOPROSTHESIS; STENT, CORONARY

Model Number	26270
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr.:the device was received for analysis.The device was received with the stent partially deployed from the device.The distal stent wires were noted to be damaged and penetrating through a section of the braided inner lining of the blue outer sheath.The investigator could not deploy the stent due to the presence of solidified blood and the damage to the stent and outer sheath.No other issues were noted with the stent.A visual and microscopic examination identified that damaged distal stent wires of the device had penetrated through the braided lining of the blue outer sheath.A section of the braided lining had been detached from the outer sheath together with the partially deployed stent.A section of the extreme distal end of the sheath and marker band were also detached from the device.This type of damage is consistent with excessive force being applied to the device.No other issues were identified with the delivery system that could potentially have contributed to the complaint incident.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 21-nov-2019.It was reported that deployment difficulties occurred.The stenosed target lesion was located in a ventriculo-atrial shunt.A 7x34x75/ iliac 6f unistep plus reduced profile wallstent was advanced but failed to deploy.The device was removed and the procedure was completed with another of the same device.No patient complications were reported.However, returned device analysis revealed stent damage and device fractures.

• Brand Name: WALLSTENT RP ENDOPROSTHESIS
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9412545
• Report Number: 2134265-2019-14881
• Device Sequence Number: 11790857
• Product Code: NIO
• UDI-Device Identifier: 08714729345671
• UDI-Public: 08714729345671
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P940019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2019

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: 04/08/2020
• Device Model Number: 26270
• Device Catalogue Number: 26270
• Device Lot Number: 0021965905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1