MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER¿; STENT, CORONARY, DRUG-ELUTING

Model Number	H7493952828270
Medical Device Problem Codes	Bent (1059); Entrapment of Device (1212); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).The complaint device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
Event or Problem Description
It was reported that stent damage occurred and removal difficulties were encountered.The target lesion was located in the right coronary artery.A 2.75x28mm promus premier stent was advanced to the proximal part of the lesion.However, the device was unable to cross and during removal of the device, the stent was hung up on the guide catheter.It was then noted that the proximal edge of the stent struts were lifted and the back edge of the stent was stuck on the guide catheter, thus, unable to remove device.The physician removed the wire, guide catheter and the stent.Re-wiring of the vessel was done and the procedure was completed with implantation of non-bsc stent.No patient complications were reported and the patient status was fine.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7372124
• Report Number: 2134265-2018-02311
• Device Sequence Number: 679907
• Product Code: NIQ
• UDI-Device Identifier: 08714729844907
• UDI-Public: 08714729844907
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/02/2018

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: 05/19/2019
• Device Model Number: H7493952828270
• Device Catalogue Number: 39528-2827
• Device Lot Number: 21424153
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 03/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1