MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE PROMUS ELEMENT¿ PLUS; STENT, CORONARY, DRUG-ELUTING

Model Number	H7493911616350
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Chest Pain (1776); Reocclusion (1985)
Date of Event	02/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
(b)(6) clinical study.It was reported that chest pain and in-stent restenosis (isr) occurred.In (b)(6) 2013, the patient presented with unstable angina and coronary angiography was performed.The target lesion was located in the distal right coronary artery (rca) with 90% stenosis and was 10 mm long with a reference vessel diameter of 3.5 mm.The target lesion was treated with pre-dilatation and placement of a 3.50 x 16 mm promus element plus drug-eluting stent.Following post-dilatation, the residual stenosis was 0%.The following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2016, the patient presented with substernal chest pain radiating to the jaw and left side of the neck and right arm.Subsequently, the patient was hospitalized on the same day.Two days later, coronary angiography was performed.The 90% isr in the mid rca was treated with balloon angioplasty and placement of a 3.5 x 15 mm non-bsc drug-eluting stent with 0% residual stenosis.The following day, the event was considered as resolved and the patient was discharged on aspirin and clopidogrel.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that the event is not related to the study device as there was no in stent restenosis on the study stent.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 6289411
• Report Number: 2134265-2017-00352
• Device Sequence Number: 19065586
• Product Code: NIQ
• UDI-Device Identifier: 08714729807605
• UDI-Public: (01)08714729807605(17)20130709(10)15455415
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/09/2013
• Device Model Number: H7493911616350
• Device Catalogue Number: 39116-1635
• Device Lot Number: 15455415
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2017
• Supplement Report FDA Received Date: 03/21/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 54 YR