MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	10601
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	03/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that vessel perforation occurred.The target lesion was located in the left circumflex (lcx) artery.Rotablation was performed with a 1.75mm rotablator burr and coronary guidewires were crossed the lesion.Pre-dilation with 1.5mm, 2.5mm and 3.0x12mm emerge balloon catheters in the proximal circumflex and distal left main artery and a 2.5x10mm wolverine balloon catheter was dilated in the proximal artery.A 4.0x24mm synergy drug-eluting stent (des) was then advanced but failed to cross the lesion.The device was removed and a 3.0x12mm synergy des was advanced to the proximal and deployed followed by a 4.0x12mm stent deployed in the distal left main and proximal circumflex artery.However, it was observed via angiogram that perforation occurred at the proximal circumflex artery.Another balloon catheter followed by a 3.0x16mm graftmaster non-bsc stent was used to cover most of the perforation.Another 4.0x12mm synergy des was deployed and post-dilated with a 5.0x8mm nc emerge balloon catheter limiting the perforation to a small trickle.The patient's anticoagulation was reversed with protamine to further promote closure of this perforation.The patient was followed closely in intensive care over the last 48 hours and is now in stable condition with a great prognosis.

• Brand Name: SYNERGY
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8515688
• Report Number: 2134265-2019-03840
• Device Sequence Number: 1928493
• Product Code: NIQ
• UDI-Device Identifier: 08714729840053
• UDI-Public: 08714729840053
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/15/2019

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: 11/18/2020
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0022980536
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/15/2019
• 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: 77 YR