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	H7493926008220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2016-12021.(b)(6).It was reported that vessel dissection occurred.In (b)(6) 2016, the patient's qualifying condition was unstable angina and was referred for cardiac catheterization.The target lesion was located in the mid left anterior descending (lad) artery extending up to distal lad with 80% stenosis and was 18mm long with a reference vessel diameter of 3.00mm.The target lesion was treated with pre-dilatation and placement of a 2.50 x 28mm and 2.25 x 8mm synergy ii stents.Following post-dilatation, the residual stenosis was 0%.However, post procedure, a grade a dissection was noted, which was treated with intervention.The following day, the patient was discharged on dual antiplatelet therapy.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that the grade a dissection occurred after the 2.50 x 28mm synergy ii stent was implanted and the 2.25 x 8mm synergy ii stent was implanted as treatment.

• 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: 6195604
• Report Number: 2134265-2016-12022
• Device Sequence Number: 730500
• Product Code: NIQ
• UDI-Device Identifier: 08714729839965
• UDI-Public: (01)08714729839965(17)20170815(10)19611086
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 12/08/2016

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: 08/15/2017
• Device Model Number: H7493926008220
• Device Catalogue Number: 39260-0822
• Device Lot Number: 19611086
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/21/2016
• Supplement Report FDA Received Date: 01/18/2017
• 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