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

Model Number	H7493952838300
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Angina (1710); Cardiac Enzyme Elevation (1838)
Date of Event	03/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device is a combination product.Device evaluated by mfr.: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.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 stent restenosis occurred and the patient experienced unstable angina and elevated troponins.In (b)(6) 2014 3.00 x 38 mm promus premier¿ stent was implanted in the left anterior descending (lad) artery.In (b)(6) 2017, the patient presented with unstable angina and slightly elevated troponin levels; 90% focal in-stent restenosis (isr) was noted.The following day, surgery was performed and predilation was completed with a 3.00 x 15 mm balloon followed by the implant of a 3.50 x 20 mm synergy stent, resulting in 0% stenosis and restored timi 3 flow.The patient went home later that day an the physician felt that the results were "excellent.".

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6453673
• Report Number: 2134265-2017-03228
• Device Sequence Number: 13606678
• Product Code: NIQ
• UDI-Device Identifier: 08714729845027
• UDI-Public: (01)08714729845027(17)20141119(10)16628721
• Combination Product (Y/N): N
• Initial Reporter State: GA
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2017

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: 11/19/2014
• Device Model Number: H7493952838300
• Device Catalogue Number: 39528-3830
• Device Lot Number: 16628721
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2017
• Initial Report FDA Received Date: 04/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention