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

Model Number	H7493911408400
Medical Device Problem Codes	Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Thrombosis (2100)
Date of Event	12/02/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is a combination product.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 most probable root cause was unable to be determined.(b)(4).
Event or Problem Description
Promus element plus clinical study.It was reported that the patient died.In (b)(6) 2012, the patient was referred for cardiac catheterization.Subsequently, index procedure was performed.The target lesion was a de novo lesion located in the left main coronary artery (lmca) involving left anterior descending (lad) artery with 70% stenosis and was 5 mm long with a unknown reference vessel diameter.The target lesion was treated with direct placement of 4.00 x 8.00 mm pe plus stent with 0% residual stenosis.Two days after, the patient was discharged on aspirin and prasugrel.In (b)(6) 2016, the patient expired.Per pi note dated (b)(6) 2017, the site became aware of patient's death while doing search on internet regarding the patient.Last contact with the patient was in (b)(6) 2016 via phone call.The cause of death was unknown.Death certificate is not available and autopsy was not performed.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that in (b)(6) 2016, stent thrombosis occurred per adjudication.

• 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: 6312760
• Report Number: 2134265-2017-00619
• Device Sequence Number: 42732
• Product Code: NIQ
• UDI-Device Identifier: 08714729808114
• UDI-Public: (01)08714729808114(17)20121120(10)14926498
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2017

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: 11/20/2012
• Device Model Number: H7493911408400
• Device Catalogue Number: 39114-0840
• Device Lot Number: 14926498
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2017
• Supplement Report FDA Received Date: 04/23/2017
• 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: Death
• Patient Age: 80 YR