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

Model Number	H7493911432270
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Angina (1710); Chest Pain (1776); Reocclusion (1985)
Date of Event	05/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: the device was not received for analysis.A review of the manufacturing documentation found that all devices shipped from the batch conformed to the preventive measures / current controls as per the product specification.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).
Event or Problem Description
(b)(6) study.It was reported that in-stent restenosis (isr) occurred.In (b)(6)2012, the patient was referred for cardiac catheterization.Subsequently, coronary angiography and the index procedure were performed.The target lesion was a de novo lesion located in mid right coronary artery (rca) with 99% stenosis and was 24.0 mm long with a reference vessel diameter of 2.75mm.The target lesion was treated with pre-dilatation and stent placement using a 2.75x32mm promus element¿ plus study stent with 0% residual stenosis.One day post procedure, the patient was discharged on aspirin and prasugrel.In (b)(6) 2017, the patient presented with complaints of chest pain and was hospitalized on the same day.It was reported that the patient had two episodes of chest pain which resolved with nitroglycerin (ntg) and the patient was presented to emergency room.On the same day, the patient was diagnosed with unstable angina with canadian class 4 symptoms after medical evaluation, myocardial infarction was ruled out and the patient was referred for a left heart catheterization to evaluation of ischemia.Due to her recurrent pain which was reveled with ntg and history of coronary artery disease and percutaneous coronary interventions, she was transferred for cardiac catheterization.99% isr of the study stent in mid rca and 50-70% stenosis in distal rca was identified and treated with pre-dilatation and placement of 3.0x18mm and 3.0x32 mm non-bsc stents in overlapping manner with residual stenosis of 10%.The following day, the event was considered resolved and the patient was discharged on the same day.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6985750
• Report Number: 2134265-2017-10752
• Device Sequence Number: 444874
• Product Code: NIQ
• UDI-Device Identifier: 08714729823698
• UDI-Public: 08714729823698
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 10/11/2017

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: 02/05/2013
• Device Model Number: H7493911432270
• Device Catalogue Number: 39114-3227
• Device Lot Number: 15093709
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 10/27/2017
• 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: 76 YR