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	H7493926028270
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Dyspnea (1816); Fatigue (1849); Chronic Obstructive Pulmonary Disease (COPD) (2237)
Date of Event	06/24/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Complaint name: (b)(4).Device is a combination product.The device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).
Event or Problem Description
(b)(4) clinical study.It was reported that the patient died.In (b)(6) 2017, clinical status assessment indicated the patient's qualifying conditions as unstable angina and silent ischemia and was further referred for cardiac catheterization.Subsequently, index procedure was performed.The target lesion was located in proximal left anterior descending (lad) artery with 70% stenosis and was 20.0 mm long with a reference vessel diameter of 2.75 mm.The target lesion was treated with pre-dilatation and placement of a 2.75 x 28 mm synergyii stent.Following post dilatation, residual stenosis was 0%.Six days after, the patient was discharged on dual antiplatelet therapy.In june 2017, the patient expired in hospice care with unknown cause.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that on (b)(6) 2017, the patient was admitted to hospice care for end-stage chronic obstructive pulmonary disease (copd).Fourteen days later, the patient complained of fatigue and shortness of breath.End stage copd was medically treated and patient was placed on oxygen support for shortness of breath.In (b)(6) 2017, the patient's general condition declined more rapidly and was unresponsive.Continued observation of the responses to the medications and pharmacologic changes were managed for patient's comfort.The patient died due to cardiorespiratory failure with a known history of oxygen dependent copd and chronic heart failure (chf).

• 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: 6735239
• Report Number: 2134265-2017-07254
• Device Sequence Number: 13854718
• Product Code: NIQ
• UDI-Device Identifier: 08714729840282
• UDI-Public: (01)08714729840282(17)20170531(10)19369929
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 07/04/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: H7493926028270
• Device Catalogue Number: 39260-2827
• Device Lot Number: 19369929
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/04/2017
• Supplement Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 07/24/2017
• Supplement Report FDA Received Date: 11/03/2017
• 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: Death
• Patient Age: 68 YR