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	H7493926024400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Hematoma (1884); Perforation of Vessels (2135)
Date of Event	05/14/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is a combination product.The device was not 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: 2134265-2018-04903 and 2134265-2018-04904.It was reported that intervention had taken place from the selective saphenous vein graft (svg) to right coronary artery (rca).The physician had decided to stent due to stenosis in the mid portion of the vessel.A 4.00x24mm synergy ii stent was implanted, and then post dilated with a 5.50x15mm balloon catheter to 20 atm, at which point the balloon still showed "waisted." a 6.00mm x 15mm nc emerge® was then advanced and inflated to a low pressure to fully expand the stent.The balloon had fully expanded and a picture was taken of the final result, which was noted to have looked like a great result.As the physician was commenting on the result, the patient complained of pain.Another picture was taken at which point a perforation was noticed in the svg.The physician placed a 5.50mm x 15mm nc emerge® at very high pressure to seal the perforation.The physician attempted to deliver a covered stent but the guide was too long.The guide was shortened and they tried to deliver the stent again, however it would not deploy suggesting it was defective.After deflating the balloon, it appeared the perforation was sealed.The patient remained hypotensive so a balloon pump was placed and a transesophageal echocardiogram (tee) was performed.The tee showed a hematoma pressing against the right ventricle with no motion.The patient was rushed to surgery for removal of the hematoma and tied off the svg.The surgeon had updated the family that the patient was in stable condition.The physician noted they did not believe the issue had been due to any defect of the stent or balloon.It was later reported that the patient had died on the day of the procedure at 6:30pm.

• 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: 7586766
• Report Number: 2134265-2018-04902
• Device Sequence Number: 13841822
• Product Code: NIQ
• UDI-Device Identifier: 08714729840251
• UDI-Public: 08714729840251
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2018

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: 01/31/2019
• Device Model Number: H7493926024400
• Device Catalogue Number: 39260-2440
• Device Lot Number: 21711838
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 06/11/2018
• 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: Death; Required Intervention
• Patient Age: 73 YR