MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	H7493926024270
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Fatigue (1849); Reocclusion (1985)
Date of Event	09/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant name: (b)(6).  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 restenosis occurred.In (b)(6) 2017, clinical status assessment indicated the patient qualifying condition as unstable angina.Subsequently, coronary angiography and index procedure were performed.The target lesion was located in the middle left anterior descending (lad) artery with 80 % stenosis and was 20mm long with a reference vessel diameter of 2.75mm.The lesion was treated with pre-dilatation and placement of a 2.75mmx24mm study stent.Following post-dilatation, residual stenosis was 0%.On the following day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2017, the patient presented to hospital for the planned catheterization and was hospitalized on the same day.The patient has stated the physician that she has been having more fatigue and shortness of breath for one month.Coronary angiography revealed mid lad with 40 -60% narrowing proximal to study stent, patent study stent, 40-50% ostial narrowing in 1st diagonal.On the same day, 60% stenosis in proximal lad extending to mid lad was treated with balloon angioplasty and placement of 3.0x24mm synergy stent in an overlapping fashion with the study stent.Following post-dilatation, the residual stenosis was 0%.Two days after, the patient was discharged on dual antiplatelet therapy.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7465275
• Report Number: 2134265-2018-03524
• Device Sequence Number: 16508043
• Product Code: NIQ
• UDI-Device Identifier: 08714729840220
• UDI-Public: 08714729840220
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2018

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: 01/19/2018
• Device Model Number: H7493926024270
• Device Catalogue Number: 39260-2427
• Device Lot Number: 0020199865
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 04/26/2018
• 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: 74 YR