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

Model Number	H7493952812220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).It is indicated that the device will not be returned for evaluation.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the left anterior descending artery.A 2.25x12mm synergy drug-eluting stent was advanced to treat the lesion.However, while advancing, it was noted that the stent delivery system (sds) broke halfway.The device was pulled out and the broken sds came with it.No patient complications were reported.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7191181
• Report Number: 2134265-2017-13289
• Device Sequence Number: 1185283
• Product Code: NIQ
• UDI-Device Identifier: 08714729844648
• UDI-Public: 08714729844648
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2017

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: 01/29/2018
• Device Model Number: H7493952812220
• Device Catalogue Number: 39528-1222
• Device Lot Number: 19571407
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 01/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1