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

Model Number	M001712180
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not received for analysis.A review of the manufacturing documentation found that all devices shipped from the batch conformed to the preventive measures / current controls as per product specification.The most probable root cause is user preference issue as the user is dissatisfied with the function, performance, or appearance of the product.(b)(4).
Event or Problem Description
It was reported that stent profile problem occurred.The stenosed, 2cm target lesion was located in the left iliac artery.An 8x38x75 wallstent rp endoprosthesis was advanced to treat the lesion.However, when the stent was deployed, it was noticed that the stent size was actually longer than the size stated on the box.The deployed stent was approximately more than 80mm.The proximal portion of the stent was placed at the orifice of the left iliac artery and at 38mm, it should not have extended below the internal iliac artery bifurcation.The deployed stent extended in the external iliac artery.No additional intervention was required and the procedure was completed with no patient complications.The patient's condition was reported to be good post procedure.

• Brand Name: WALLSTENT¿ RP ENDOPROSTHESIS
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6855848
• Report Number: 2134265-2017-08795
• Device Sequence Number: 801131
• Product Code: MAF
• UDI-Device Identifier: 08714729345749
• UDI-Public: (01)08714729345749(17)20180907(10)0019689586
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P940019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/16/2017

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: 09/07/2018
• Device Model Number: M001712180
• Device Catalogue Number: 71-218
• Device Lot Number: 0019689586
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 09/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1