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

Model Number	H7493911608300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Chest Pain (1776); Dyspnea (1816)
Date of Event	04/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: the 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
Same case as mdr: 2134265-2017-06187.(b)(6) clinical study.It was reported that unstable angina occurred.In (b)(6) 2012, the patient presented due to unstable angina and was referred for cardiac catheterization.Subsequently, index procedure was performed.The target lesion was a 90% in-stent restenosis of a previously implanted unspecified drug eluting stent (des) located in the first obtuse marginal (om1) and was 6.0mm long with a reference vessel diameter of 3.00mm.The lesion was treated with direct stent placement using a 3.00x8mm promus element¿ plus study stent, with 0% residual stenosis.One day post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2014, a 16 x 2.25mm promus premier¿ des was implanted in om1.In (b)(6) 2017, the patient presented with chest pain associated with shortness of breath.Eighteen days later, the patient was planned for possible coronary artery bypass grafting (cabg), as the patient's coronary intervention options has decreased.In (b)(6) 2017, patient was hospitalized for the planned surgery.Cabg was performed including left internal mammary artery (lima) to distal left anterior descending (lad) and saphenous vein graft (svg) to left ventricular bypass (lvb).Additionally on the same day, transmyocardial laser revascularization of lateral wall and placement of swan-ganz catheter were performed as obtuse marginal was not bypassable.Seven days later, the event was considered to be resolved and the patient was discharged from the hospital.

• 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: 6652759
• Report Number: 2134265-2017-06186
• Device Sequence Number: 19120157
• Product Code: NIQ
• UDI-Device Identifier: 08714729807582
• UDI-Public: (01)08714729807582(17)20121221(10)14987604
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 05/31/2017

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: 12/21/2012
• Device Model Number: H7493911608300
• Device Catalogue Number: 39116-0830
• Device Lot Number: 14987604
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2017
• Initial Report FDA Received Date: 06/19/2017
• 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
• Patient Age: 63 YR