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

Model Number	H7493911412270
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	09/01/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is a combination product.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 is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event.(b)(4).
Event or Problem Description
(b)(4) clinical study.It was reported that the patient died.In (b)(6) 2012, the patient presented with unstable angina.Subsequently, the patient was referred for cardiac catheterization.The target lesion was a de novo lesion located in the mid left anterior descending (lad) artery with 98% stenosis.The lesion was treated with direct placement of 2.75x12mm promus element¿ plus drug-eluting stent with 0% residual stenosis.One day post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2017, the patient expired.The cause of death was unknown.It was also unknown whether an autopsy was performed or not.In (b)(6) 2017, the site became aware of the patient's death during 5 year follow-up via phone call.The patient was not visited since 2014; however, she was last contacted in (b)(6) 2016 during 4 year follow-up.The patient¿s phone number was disconnected and further contact information is not available.
Additional Manufacturer Narrative
Describe event or problem updated.(b)(4).
Event or Problem Description
It was adjudicated that possible stent thrombosis occurred.

• 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: 7141028
• Report Number: 2134265-2017-12881
• Device Sequence Number: 69072
• Product Code: NIQ
• UDI-Device Identifier: 08714729807889
• UDI-Public: 08714729807889
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 12/08/2017

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: 06/14/2013
• Device Model Number: H7493911412270
• Device Catalogue Number: 39114-1227
• Device Lot Number: 15398553
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/08/2017
• Supplement Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 03/02/2018
• 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: 81 YR