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

Model Number	H7493911416300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Myocardial Infarction (1969)
Date of Event	12/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).
Event or Problem Description
(b)(6) clinical study.It was reported that myocardial infarction (mi) and chest pain occurred.In (b)(6) 2012, the patient was referred for cardiac catheterization.Subsequently, the index procedure and coronary angiography were performed.The target lesion was a de novo lesion located in the proximal left anterior descending (lad) artery with 85% stenosis and was 10mm long with a reference vessel diameter of 3.0mm.The target lesion was treated with pre-dilatation and placement of a 3.00x16mm promus element plus drug-eluting study stent with 0% residual stenosis.The following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2016, the patient presented to study hospital due to chest pain and was hospitalized on the same day.The patient was non-compliant with anti-platelet medications for 2 months.The patient was further referred for cardiac catheterization.The 95% stenosis of the proximal left circumflex artery was treated with cutting balloon angioplasty with 0% residual stenosis.Additionally, the 100% stenosis of the proximal right coronary artery (rca) was treated with placement of unknown stent.Post procedure, after the sheath pull, the patient experienced bleeding from the right groin site.Later, right groin ultrasound revealed hematoma and lab investigations revealed no significant drop in the hemoglobin.Subsequently, the mi was considered resolved.Two days after, the patient was discharged on aspirin.
Additional Manufacturer Narrative
Describe event or problem and relevant tests/lab data updated.(b)(4).
Event or Problem Description
It was further reported that the study stent in the proximal lad was patent.Therefore, the events occurred are not related to the study device.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6414342
• Report Number: 2134265-2017-02218
• Device Sequence Number: 16375128
• Product Code: NIQ
• UDI-Device Identifier: 08714729807957
• UDI-Public: (01)08714729807957(17)20130308(10)15171523
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2017

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: 03/08/2013
• Device Model Number: H7493911416300
• Device Catalogue Number: 39114-1630
• Device Lot Number: 15171523
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/28/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2017
• Supplement Report FDA Received Date: 06/12/2017
• 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: 71 YR