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	H7493926032400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intimal Dissection (1333); Chest Pain (1776)
Date of Event	05/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: the complaint 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: 2134265-2017-05440 and 2134265-2017-05441.(b)(6).It was reported that vessel dissection and chest pain occurred.In (b)(6) 2017, clinical status assessment indicated that the patient's qualifying condition as stable angina and was referred for cardiac catheterization.Subsequently, index procedure was performed.Target lesion #1 was located in the proximal right coronary artery (rca) with 75% stenosis and was 32 mm long with a reference vessel diameter of 4.00 mm.The lesion was treated with pre-dilatation and placement of 4.00 x 38 mm and 3.50 x 38 mm study stents.Following post-dilatation residual stenosis was 0%.Target lesion #2 was located in the mid rca with 60% 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 a 4.00 x 32 mm study stent.Following post-dilatation residual stenosis was 0%.Post procedure, following treatment of the target lesion, grade d dissection was noted.The dissection was treated with intervention.Cardiac chest pain had also occurred during percutaneous coronary intervention (pci).The following day, the patient was discharged on aspirin and clopidogrel.

• 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: 6607784
• Report Number: 2134265-2017-05442
• Device Sequence Number: 18890043
• Product Code: NIQ
• UDI-Device Identifier: 08714729840374
• UDI-Public: (01)08714729840374(17)20170628(10)19442101
• 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
• Report Date (Section B): 05/12/2017

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: 06/28/2017
• Device Model Number: H7493926032400
• Device Catalogue Number: 39260-3240
• Device Lot Number: 19442101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2017
• Initial Report FDA Received Date: 06/02/2017
• 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: 68 YR