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

Model Number	26270
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that removal difficulties occurred.The 50% stenosed target lesion was located in the severely tortuous and non-calcified shunt.A 6x59x75/ iliac 6f unistep plus reduced profile wallstent was selected for use.However, after deploying the stent, the system was caught on the most bent part of the stent and could not be removed.It was repeatedly pushed and pulled for several times and was removed after changing the angle directly above the skin.The procedure was completed with another of same device.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that removal difficulties occurred.The 50% stenosed target lesion was located in the severely tortuous and non-calcified shunt.A 6x59x75/ iliac 6f unistep plus reduced profile wallstent was selected for use.However, after deploying the stent, the system was caught on the most bent part of the stent and could not be removed.It was repeatedly pushed and pulled for several times and was removed after changing the angle directly above the skin.The procedure was completed with another of same device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
E1 - initial reporter city: (b)(6).Device evaluated by mfr.: received wallstent rp 6fr device with no stent.A visual examination found that the stent of the device had been deployed.The stent was not returned for analysis as it was implanted inside the patient.A visual inspection of the stent impression and stent cups identified no issues.The imprinted stent impression was clear on the stent holder.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination identified no issues along the length of the device.No other issues were identified during the product analysis.

• 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: 10465461
• Report Number: 2134265-2020-11921
• Device Sequence Number: 19555429
• Product Code: NIO
• UDI-Device Identifier: 08714729345640
• UDI-Public: 08714729345640
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2020

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: 06/16/2021
• Device Model Number: 26270
• Device Catalogue Number: 26270
• Device Lot Number: 0023961013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MOSQUITO6F INTRODUCER SHEATH; MOSQUITO6F INTRODUCER SHEATH; RADIFOCUS 0.035 GUIDEWIRE; RADIFOCUS 0.035 GUIDEWIRE