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

Model Number	26270
Medical Device Problem Codes	Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter city: (b)(6).Device evaluated by mfr.: a 6x24x75/ iliac 6f unistep plus was received for analysis.The device was received with the stent partially deployed in the correct position on the device.The stent was successfully deployed with a little resistance due to a severe shaft kink.A visual examination identified damage to the distal stent wires and center of the deployed stent.Which is at the same location as the shaft kink before the stent was deployed.The inner and outer shafts were found to be severely kinked at several locations along its length.A visual examination identified no damage or issues with the tip of the device that could potentially have contributed to the complaint incident.The damaged found is consistent with resistance being encountered during an attempt to deploy the stent.
Event or Problem Description
Reportable based on device analysis completed on 09-jun-2022.It was reported that stent deployment issues occurred.The 95% stenosed target lesion was located in a thin shunt of the forearm vein.A 4-40 symmetry balloon catheter was advanced for dilatation.However, the device failed to cross the lesion.A non- boston scientific balloon catheter was advanced and dilatation was performed.Subsequently, a 6x24x75cm wallstent rp endoprosthesis stent was advanced for treatment.However, it was noted that the outer shaft was too hard to pull.The procedure was completed with another 7-23 wallstent.There were no patient injuries reported.However, returned device analysis revealed stent damaged.

• Brand Name: WALLSTENT RP ENDOPROSTHESIS
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14851834
• Report Number: 2134265-2022-06928
• Device Sequence Number: 20032121
• Product Code: NIO
• UDI-Device Identifier: 08714729345589
• UDI-Public: 08714729345589
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P940019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2022

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: 05/12/2023
• Device Model Number: 26270
• Device Catalogue Number: 26270
• Device Lot Number: 0027300824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER: SYMMETRY 4-40; GUIDEWIRE: GT16 WIRE; INTRODUCER SHEATH: ULTRA HIGH FLOW SHEATH
• Patient Sex: Unknown