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

Model Number	10602
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The 90% stenosed target lesion was located in the severely tortuous and moderately calcified proximal circumflex artery.After a guidewire crossed the lesion and 5.5f non-boston scientific guide extension catheter was placed, the distal lesion was dilated with a 2.5x12 compliant balloon.A 4.00 x 16mm synergy ii drug-eluting stent was advanced in the left main but failed to cross the lesion.Upon withdrawal, the stent dislodged from the stent delivery balloon.An attempt was made to recross the undeployed stent with the delivery balloon.Subsequently, the system delivery balloon was removed and a 2.0x12 compliant balloon was advanced which partially deployed the stent.A 4.0x12mm complaint balloon was advanced and fully expanded the stent in the left main.After wire and guide removal, the procedure was completed.No patient complications were reported and the patient condition was good.

• 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: 10928292
• Report Number: 2134265-2020-16727
• Device Sequence Number: 4295635
• Product Code: NIQ
• UDI-Device Identifier: 08714729840138
• UDI-Public: 08714729840138
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/01/2020

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: 09/09/2021
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0024442846
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 12/01/2020
• 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: 2.0X12 AND 4.0X12 COMPLIANT BALLOONS; GUIDE EXTENSION CATHETER: GUIDELINER 5.5F
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR