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	H7493926016270
Medical Device Problem Codes	Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Thrombosis (2100)
Date of Event	02/03/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: the device was not returned for evaluation.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
Same case as: 2134265-2017-02077.Clinical study: (b)(4).On (b)(6) 2016 the subject was enrolled in the (b)(6) study.Target lesion #1 was located in the 2nd obtuse marginal artery with 80% stenosis and was 12.0 mm long with 2.50 mm reference vessel diameter.The lesion was treated with pre-dilatation and placement of a 2.50 x 16 mm synergy stent was performed and following post-dilatation residual stenosis was 0%.Target lesion #2 was located in the proximal left circumflex artery with 70% stenosis and was 12.0 mm long with 2.75 mm reference vessel diameter.The lesion was treated with direct placement of a 2.75 x 16 mm synergy stent.Following post-dilatation residual stenosis was 0%.Target lesion #3 was located in the 1st obtuse marginal artery with 65% stenosis and was 3.00 mm long with 3.00 mm reference vessel diameter.The lesion was treated with balloon angioplasty, no stent was deployed.Following balloon angioplasty, the residual stenosis was 30%.The subject was discharged later that day on dual antiplatelet therapy (aspirin and clopidogrel).On (b)(6) 2017 the patient died.The cause of death is unknown.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that the patient presented in (b)(6) 2016 with aortic stenosis, coronary artery disease and shortness of breath.Subsequently the index procedure was performed.In (b)(6) 2017 the patient came in for pre-operative out-patient evaluation prior to target catheter aortic valve replacement.Ct angiogram was performed and revealed no acute intrathoracic abnormality, however the patient had severe chronic obstructive pulmonary disease.In (b)(6) 2017 the patient passed away at home in his sleep and no autopsy was performed.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that potential stent thrombosis had occurred.

• 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: 6412688
• Report Number: 2134265-2017-02078
• Device Sequence Number: 13682763
• Product Code: NIQ
• UDI-Device Identifier: 08714729840107
• UDI-Public: (01)08714729840107(17)20170824(10)19660089
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2017

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: 08/24/2017
• Device Model Number: H7493926016270
• Device Catalogue Number: 39260-1627
• Device Lot Number: 19660089
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/23/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/17/2017
• Supplement Report FDA Received Date: 04/12/2017; 05/25/2017
• 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: 89 YR