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

Model Number	H7493952812250
Medical Device Problem Codes	Bent (1059); Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, 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 catheter removal difficulties were encountered and stent damage occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified first diagonal branch.A 2.50x12mm promus premier¿ drug-eluting stent was advanced but failed to cross the lesion.The physician had a hard time removing the device and once completely removed, it was noted that the distal portion of the stent struts was mangled.After removal of the device, pre-dilatation was performed with a 2.5x15mm emerge balloon catheter and a 2.5x8mm promus stent was used to complete the procedure.No patient complications were reported and the patient's status was stable.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6962607
• Report Number: 2134265-2017-10378
• Device Sequence Number: 13758439
• Product Code: NIQ
• UDI-Device Identifier: 08714729844655
• UDI-Public: 08714729844655
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/04/2017

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: 01/01/2019
• Device Model Number: H7493952812250
• Device Catalogue Number: 39528-1225
• Device Lot Number: 20873880
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1