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

Model Number	9371
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reocclusion (1985)
Date of Event	02/18/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that restenosis occurred.In (b)(6) 2012, the patient presented with unstable angina and st-segment elevation inferior wall myocardial infarction.Subsequently, coronary angiography and the index procedure was performed.Target lesion was a de novo and culprit lesion for stemi located in mid right coronary artery (rca) with 99% stenosis and timi flow 1.It was 22mm long with a reference vessel diameter of 3.50mm.The target lesion was treated with pre-dilatation using 2.5 x 20mm emerge balloon catheter and a 3.0 x 20mm emerge balloon, followed by a 3.50 x 28mm promus element plus drug-eluting stent, which was placed with 0% residual stenosis and timi 3 flow.After two days, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2014, the patient presented in cardiology department for follow-up care with complains of chest pain in the middle of the chest with some radiation towards left shoulder with exertion.The patient stated that the pain was noticed while using arms and it resolved after 1-2 minutes with rest.Subsequently, the patient was scheduled for a left heart catheterization eleven days later.The 99% severe subtotal proximal occlusion located just prior to the proximal study stent edge was treated using pre-dilatation and placement of a 3.50 x 16mm promus drug-eluting stent.Following, post-dilatation there was no residual stenosis, no proximal distal edge dissections and timi grade 3 flow.The patient was then taken to the clinical decision unit for overnight observation.On the next day, the patient remained stable overnight and the event was resolved and the patient was discharged on aspirin and clopidogrel.

• Brand Name: PROMUS ELEMENT PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• MDR Report Key: 7764922
• Report Number: 2134265-2018-60047
• Device Sequence Number: 11077338
• Product Code: NIQ
• UDI-Device Identifier: 08714729807636
• UDI-Public: 08714729807636
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 08/08/2018

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: 12/18/2012
• Device Model Number: 9371
• Device Catalogue Number: 9371
• Device Lot Number: 14974157
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 08/08/2018
• 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: Required Intervention
• Patient Age: 54 YR