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

Model Number	H7493911416400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	03/11/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: the complaint device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion 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) 2013, the patient was diagnosed with unstable angina.Subsequently, the patient was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion# 1 was located in the first obtuse marginal branch with 80% in-stent restenosis of a previously deployed unknown drug-eluting stent (des) and was 14mm long with reference vessel diameter of 4 mm.The lesion was treated with pre-dilatation and placement of a 4.00 x16mm promus element¿ plus des.Following post dilatation, residual stenosis was 20%.One day post procedure, the patient was discharged on aspirin and ticagrelor.During the 5-year follow-up, the site became aware that the patient was in a nursing home and was not assessable for the follow-up.The patient expired in the nursing home on an unknown date of unknown cause.
Additional Manufacturer Narrative
Death date, event date, and describe event or problem: updated.(b)(4).
Event or Problem Description
It was further reported that the patient died in (b)(6).

• 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: 7397992
• Report Number: 2134265-2018-02771
• Device Sequence Number: 592444
• Product Code: NIQ
• UDI-Device Identifier: 08714729808077
• UDI-Public: 08714729808077
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 03/14/2018

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: 06/12/2013
• Device Model Number: H7493911416400
• Device Catalogue Number: 39114-1640
• Device Lot Number: 15393047
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/14/2018
• Supplement Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 05/21/2018
• 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: 77 YR