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	H7493926012270
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Vessels (2135); No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant name: (b)(6) medical center.Device is a combination product.It is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
(b)(4) clinical study.It was reported that vessel perforation occurred.In (b)(6) 2017, patient's clinical status assessment indicated the patient's qualifying condition as stable angina and silent ischemia.The patient was referred for cardiac catheterization and index procedure was performed.The target lesion was located in the proximal left anterior descending artery (lad) with 80% stenosis and was 25.0mm long with a reference vessel diameter of 3.00mm.The lesion was treated with direct placement of a 3.00x28mm study stent.Following post dilatation, residual stenosis was 0%.Target lesion #2 was located in the distal left circumflex artery (lcx) with 80% stenosis and was 70mm long with a reference vessel diameter of 2.75mm.The lesion was treated with direct placement of a 2.75x12mm synergy ii stent, however, following stent deployment vessel perforation was noted.Following post dilatation, residual stenosis was 0%.On the same day, the patient was discharged on dual antiplatelet therapy.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that no vessel perforation 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: 7204612
• Report Number: 2134265-2017-13336
• Device Sequence Number: 16404852
• Product Code: NIQ
• UDI-Device Identifier: 08714729840046
• UDI-Public: 08714729840046
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2017

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: 05/23/2018
• Device Model Number: H7493926012270
• Device Catalogue Number: 39260-1227
• Device Lot Number: 20705090
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/26/2017
• Supplement Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 01/18/2018
• Supplement Report FDA Received Date: 02/14/2018
• 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
• Patient Age: 83 YR