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	H7493926024350
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	11/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that a vessel dissection occurred.The target lesion was located in the right coronary artery (rca).Following pre-dilation, a 3.50 x 24mm synergy ii dug-eluting stent was advanced but failed to cross the lesion.Ultimately, a vessel dissection occurred.The patient was then sent to surgery for bypass.No further patient complications were 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: 7081919
• Report Number: 2134265-2017-11685
• Device Sequence Number: 1234835
• Product Code: NIQ
• UDI-Device Identifier: 08714729840244
• UDI-Public: 08714729840244
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2017

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: 08/08/2018
• Device Model Number: H7493926024350
• Device Catalogue Number: 39260-2435
• Device Lot Number: 21030769
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 12/05/2017
• 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: Other