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	H7493926028270
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Ventricular Fibrillation (2130); Perforation of Vessels (2135); Obstruction/Occlusion (2422)
Date of Event	01/05/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
Same case as mdr ids: 2134265-2017-00288, 2134265-2017-00290, 2134265-2017-00291.It was reported that vessel perforation, ventricular fibrillation, slow flow and patient's death occurred.This was a very high risk procedure on a very compromised patient.The target lesion was located in the calcified proximal to distal left anterior descending (lad) artery.Four synergy ii drug-eluting stents of size 3.00x16mm, 2.75x28mm, 2.5x24mm, and 2.25x20mm were implanted from proximal to distal lesion in order.After the deployment of the last 2.25x20mm stent, the physician pulled the balloon back approximately 10-15mm and re-inflated the balloon approximately at 26 atmospheres.However, on the next injection, a large perforation was noted in lad.The patient's condition was continuously getting worse as the physician attempted to seal the perforation and do a simultaneous pericardial tap.Eventually, the physician was able to perform the tap and deployed a 2.80x26mm non-bsc stent.Subsequently, the patient's condition continued to worsen.The patient had multiple episodes of ventricular fibrillation arrest and had limited flow in the coronary arteries.Multiple efforts were made to rescue the patient but the procedure was halted with the patient's death.
Additional Manufacturer Narrative
Describe event or problem updated.(b)(4).
Event or Problem Description
It was further reported that coronary artery disease was the official cause of death.There was no relationship between the stents and the patient outcome as per physician's opinion and medical judgment.The physician stated that, "patient procedure was done as a rescue for cardiogenic shock.The perforation wasn't the reason for the outcome".

• 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: 6278666
• Report Number: 2134265-2017-00289
• Device Sequence Number: 731553
• Product Code: NIQ
• UDI-Device Identifier: 08714729840282
• UDI-Public: (01)08714729840282(17)20170830(10)19689822
• 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,Followup
• Report Date (Section B): 01/06/2017

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: 08/30/2017
• Device Model Number: H7493926028270
• Device Catalogue Number: 39260-2827
• Device Lot Number: 19689822
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2017
• Supplement Report FDA Received Date: 02/17/2017
• 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: Death
• Patient Age: 75 YR