MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLSTENT¿ RP ENDOPROSTHESIS; STENT, CORONARY

Model Number	M001712360
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).
Event or Problem Description
It was reported that a foreign matter was found stuck on the device.The 99% stenosed target lesion was located in the mildly tortuous and severely calcified external iliac artery.Following pre-dilation, a 10x49x75/ iliac 6f wallstent¿ rp endoprosthesis was successfully implanted for treatment.However, when the delivery shaft of the device was checked after the procedure was completed, it was noted that a white fluff was sticking on the shaft.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr., eval summary attached, method codes, result codes, and conclusion codes updated.  device evaluated by mfr.: device was returned for analysis.The wallstent iliac device was returned with the stent fully deployed from the delivery system and a white fibrous material was noted to be attached to the delivery system.A sample of the foreign material was sent for fourier transform infrared radiation (ftir) analysis.Ftir analysis confirmed that the foreign material was a polyethylene terephthalate (polyester) fibre with adhesive attached to it.No issues were identified with the stent holder.The stent cups were noted to be damaged.This type of damage is consistent with excessive force being applied to the device during stent deployment.The shaft of the device was noted to be severely kinked at approximately 235mm distal of the main valve.This type of damage is consistent with excessive force being applied to the device when encountering resistance.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion was unable to be determined.  (b)(4).
Event or Problem Description
It was reported that a foreign matter was found stuck on the device.The 99% stenosed target lesion was located in the mildly tortuous and severely calcified external iliac artery.Following pre-dilation, a 10x49x75/ iliac 6f wallstent¿ rp endoprosthesis was successfully implanted for treatment.However, when the delivery shaft of the device was checked after the procedure was completed, it was noted that a white fluff was sticking on the shaft.No patient complications were reported and the patient's status was stable.

• Brand Name: WALLSTENT¿ RP ENDOPROSTHESIS
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7588229
• Report Number: 2134265-2018-05085
• Device Sequence Number: 1555204
• Product Code: MAF
• UDI-Device Identifier: 08714729345909
• UDI-Public: 08714729345909
• Combination Product (Y/N): N
• PMA/510(K) Number: P940019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2018

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: 10/13/2019
• Device Model Number: M001712360
• Device Catalogue Number: 71-236
• Device Lot Number: 0021255553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Initial Date Received by Manufacturer: 05/20/2018
• Supplement Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 07/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1