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

Model Number	H7493952824300
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).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
Same case as mdr id# 2134265-2017-08692.It was reported that balloon rupture occurred.A 3.00x24mm promus premier¿ drug-eluting stent was advanced for treatment.However, during the procedure, the distal tip of the balloon ruptured and the stent was not implanted.Subsequently, a 2.25x12mm promus premier¿ drug-eluting stent was selected to treat a different vessel.However, during unpacking, it was noted that the stent appeared to be damaged and was not crimped well on the balloon.The device never entered the patient's body and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6833939
• Report Number: 2134265-2017-08691
• Device Sequence Number: 58781
• Product Code: NIQ
• UDI-Device Identifier: 08714729844853
• UDI-Public: (01)08714729844853(17)20180925(10)0020491094
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/15/2017

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: 09/25/2018
• Device Model Number: H7493952824300
• Device Catalogue Number: 39528-2430
• Device Lot Number: 0020491094
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1