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	H7493926008250
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Chest Pain (1776); Occlusion (1984)
Date of Event	10/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.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 mfr report#: 2134265-2017-11206, 2134265-2017-11207, 2134265-2017-11208, 2134265-2017-11213.It was reported that the stent was under expanded and the patient had chest pain, an occlusion and cardiac arrest.The target lesion was located in the heavily calcified ostial right coronary artery (rca).Pre-dilation was performed with a 2.5mm nc emerge balloon to 28 atms, which didn't expand the lesion.Then a 1.50mm rotablator rotalink plus burr was used.After that a 2.5x8mm non-bsc stent was implanted in the proximal rca and a 2.50x8mm synergy stent was implanted in the ostium.Post-dilation was performed with a 2.5mm nc emerge balloon to 28 atms, but never fully expended both stents.It was decided to leave it at this point.About 45 minutes later the patient had chest pain in the holding area and was brought back to the lab.The rca was found occluded and the patient arrested.Cardiopulmonary resuscitation (cpr) was started via a non-bsc chest compression system and the rca was re-wired and re-ballooned.A blood thinner was administered and then the rca had better flow and the patient stabilized.The patient was also put on extracorporeal membrane oxygenation (ecmo).The left ventricular function had improved back to 55% and the patient was "doing better".The physician attributed the event to severe stent under-expansion due to the heavy calcium burden.

• 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: 7034347
• Report Number: 2134265-2017-11205
• Device Sequence Number: 1345357
• Product Code: NIQ
• UDI-Device Identifier: 08714729839972
• UDI-Public: 08714729839972
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 10/30/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/04/2018
• Device Model Number: H7493926008250
• Device Catalogue Number: 39260-0825
• Device Lot Number: 0020146396
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.5X8MM RESOLUTE ONYX STENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR