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	H7493926008300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	10/30/2017
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 investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2017-11815.It was reported that vessel dissection occurred.In (b)(6) 2017, clinical status assessment indicated the patient's qualifying condition was unstable angina and the patient was referred for elective cardiac catheterization.The target lesion was located in the proximal left anterior descending (lad) with 75% stenosis and was 24mm long with a reference vessel diameter of 3.00mm.The target lesion was treated with direct placement of 3.00x24mm and 3.00x8mm study stents.Following post dilatation, the residual stenosis was 0%.On the same day, a dissection was noted at the proximal lad and an interventional procedure was performed.One day, post procedure, the patient was discharged on dual antiplatelet therapy.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that the 3.00x24mm study stent caused the dissection which was treated with the 3.00x8mm study stent.

• 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: 7081895
• Report Number: 2134265-2017-11816
• Device Sequence Number: 13771275
• Product Code: NIQ
• UDI-Device Identifier: 08714729839996
• UDI-Public: 08714729839996
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/13/2017

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: 02/06/2018
• Device Model Number: H7493926008300
• Device Catalogue Number: 39260-0830
• Device Lot Number: 0020267895
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2017
• Supplement Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 12/28/2017
• 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: 81 YR