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

Model Number	M001712320
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr.: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
Event or Problem Description
It was reported that stent foreshortening occurred.The 90% stenosed target lesion was located in the mildly tortuous cephalic vein.A 10x20x75 wallstent¿ rp endoprosthesis was successfully deployed however; it was noted that the stent had foreshortened.A 8x38 wallstent¿ rp endoprosthesis was deployed to fully cover the lesion.No further patient complications were reported and the patient's status was good.

• Brand Name: WALLSTENT¿ RP ENDOPROSTHESIS
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6807944
• Report Number: 2134265-2017-08199
• Device Sequence Number: 1565933
• Product Code: MAF
• UDI-Device Identifier: 08714729345862
• UDI-Public: (01)08714729345862(17)20190124(10)20201635
• Combination Product (Y/N): N
• 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): 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/24/2019
• Device Model Number: M001712320
• Device Catalogue Number: 71-232
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 08/21/2017
• 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: GUIDEWIRE: 035RADIFOCUS; INTRODUCER SHEATH: 6F3CM
• Outcome Attributed to Adverse Event: Required Intervention