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

Model Number	H7493911416250
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	01/28/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
(b)(6) clinical study.It was reported that the patient died.In (b)(6) 2013, the patient was diagnosed with unstable angina.Subsequently, coronary angiography and index procedure were performed.The target lesion was a de novo lesion located in the first diagonal with 85% stenosis and was 12 mm long with a reference vessel diameter of 2.5 mm.The lesion was treated by direct placement of a 2.50 x 16 mm promus element¿ plus study stent.Following post-dilatation, residual stenosis was 0%.One day post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2017, the patient died.
Additional Manufacturer Narrative
Describe event or problem, patient codes and device codes updated.(b)(4).
Event or Problem Description
It was further reported that adjudication indicated stent thrombosis.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6361492
• Report Number: 2134265-2017-01551
• Device Sequence Number: 16311850
• Product Code: NIQ
• UDI-Device Identifier: 08714729807834
• UDI-Public: (01)08714729807834(17)20131130(10)15774165
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 02/10/2017

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: 11/30/2013
• Device Model Number: H7493911416250
• Device Catalogue Number: 39114-1625
• Device Lot Number: 15774165
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2017
• Supplement Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 02/27/2017
• Supplement Report FDA Received Date: 08/11/2017
• 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: 82 YR