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

Model Number	H7493911420300
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Chest Pain (1776); Reocclusion (1985)
Date of Event	08/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.It is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
(b)(4) clinical study.It was reported that in-stent restenosis (isr) and target vessel revascularization (tvr) occurred.In (b)(6) 2013, the patient¿s qualifying condition was stable angina.Prior to the procedure, the patient was also found to have other objective evidence of ischemia and the patient was referred for cardiac catheterization.Subsequently, index procedure was performed.The target lesion was located in distal left circumflex (lcx)/mid lcx with 80% stenosis, and was 14 mm long with a reference vessel diameter of 3 mm.The lesion was treated with pre-dilatation and placement of a 3.00 x 20 mm study stent with 0% residual stenosis.One day post procedure, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2016, the patient presented with complaints of exertional chest pain and was hospitalized on the same day.Subsequently, the subject was referred to cardiac catheterization.Patient¿s coronary angiography revealed 80% stenosis located in the proximal lcx and was treated with the deployment of 3.5 x 12mm synergy drug-eluting stent in an overlapping manner with the previously placed stents with 0% residual stenosis and timi 3 flow.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6914975
• Report Number: 2134265-2017-09587
• Device Sequence Number: 1182233
• Product Code: NIQ
• UDI-Device Identifier: 08714729807964
• UDI-Public: 08714729807964
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 09/11/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/29/2013
• Device Model Number: H7493911420300
• Device Catalogue Number: 39114-2030
• Device Lot Number: 15511519
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 10/05/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 44 YR