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

Model Number	H7493911616250
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Angina (1710); Chest Pain (1776); Reocclusion (1985)
Date of Event	11/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.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 investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).
Event or Problem Description
(b)(6) clinical study.It was reported that chest discomfort and in-stent restenosis occurred.In (b)(6) 2013, the subject presented with silent ischemia and was diagnosed with stable angina.The subject was then referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion was a de novo lesion located in the distal left circumflex artery (lcx) with 80% stenosis and was 12 mm long with a reference vessel diameter of 2.5 mm.It was treated with pre-dilatation and placement of a 2.50 x 16 mm promus element¿ plus study stent.Following post-dilatation, residual stenosis was 0%.On the same day, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2017, the subject presented with progressive accelerating exertional chest discomfort.Subsequently, the subject was hospitalized and coronary angiography was permed which revealed an 80% in-stent restenosis (isr) of the previously implanted 2.50 x 16 mm promus element¿ plus study stent in distal lcx.The stress test performed on the same day revealed distal, anterior, apical and posterolateral lateral wall ischemia.The subject was hospitalized and referred for cardiac catheterization.The 80% isr of distal lcx was treated with pre-dilation and placement of 2.25 x 32 mm synergy drug eluting stent within the previously placed proximal and distal stents.Following post-dilatation, residual stenosis was 0%.The following day, subject was discharged in stable ambulatory condition.
Additional Manufacturer Narrative
Describe event or problem, relevant tests/lab data, other relevant history, and patient code updated.(b)(4).
Event or Problem Description
It was further reported that the patient had progressive angina and slight elevation of troponin.

• 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: 7409162
• Report Number: 2134265-2018-02816
• Device Sequence Number: 16171354
• Product Code: NIQ
• UDI-Device Identifier: 08714729807360
• UDI-Public: 08714729807360
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/16/2018

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: 01/22/2013
• Device Model Number: H7493911616250
• Device Catalogue Number: 39116-1625
• Device Lot Number: 0015058086
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2018
• Supplement Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 04/09/2018
• Supplement Report FDA Received Date: 06/05/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR