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	H7493926012400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	05/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 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
Same case as mdr id: 2134265-2017-05458 (b)(6) clinical study.It was reported that vessel dissection occurred.In (b)(6) 2017, clinical status assessment identified the patient¿s qualifying condition as stable angina (ccs classification: 3).Subsequently, index procedure were performed.The target lesion was located in the proximal right coronary artery (rca) with 90% stenosis and was 12 mm long with a reference vessel diameter of 4.00 mm.The lesion was treated with pre-dilatation and placement of two 4.00 x 12 mm study stents.Following post-dilatation, residual stenosis was 0%.Following treatment of the target lesion, dissection was noted and an intervention was performed to treat the dissection.Two days later, the patient was discharged on dual antiplatelet therapy aspirin and clopidogrel.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that the cause of dissection was "guide induced" after the stent placement and not due to the stent as previously reported.

• 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: 6619092
• Report Number: 2134265-2017-05456
• Device Sequence Number: 788495
• Product Code: NIQ
• UDI-Device Identifier: 08714729840077
• UDI-Public: (01)08714729840077(17)20180131(10)20248713
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 05/15/2017

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: 01/31/2018
• Device Model Number: H7493926012400
• Device Catalogue Number: 39260-1240
• Device Lot Number: 20248713
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2017
• Supplement Report FDA Received Date: 06/21/2017
• 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: Required Intervention
• Patient Age: 66 YR