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

Model Number	10604
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulty and shaft break occurred.The 90% stenosed, eccentric, target lesion containing a 90 degrees bend was located in the proximal left anterior descending artery (lad).Following pre-dilatation with a 3.0x20mm balloon, a 3.00x24mm synergy ii drug-eluting stent was delivered and deployed at 14 atmospheres.However, the balloon would not retract.The balloon inflated and deflated twice but still could not be removed.The physician tried removing by pulling harder with guide engaged more into the left main but the distal balloon was separated from the shaft and remained inside the artery.The physician had a wire in circumflex artery and in lad artery.The physician put a torquer on both wires and torqued until resistance was felt on the wires.The balloon and both the wires were then removed.The procedure was completed with no complications and the patient was doing well.

• 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: 10985270
• Report Number: 2134265-2020-17259
• Device Sequence Number: 19658132
• Product Code: NIQ
• UDI-Device Identifier: 08714729840237
• UDI-Public: 08714729840237
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/10/2020

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: 07/21/2021
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0024187151
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 12/10/2020
• 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: 74 YR