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

Model Number	10607
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the heavily calcified proximal left anterior descending (lad) artery.Following rotablation, a 3.50 x 38 synergy stent was deployed for treatment.Upon withdrawing the stent delivery system, the shaft broke inside the guide catheter.No patient complications were reported; however, the procedure was delayed.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the heavily calcified proximal left anterior descending (lad) artery.Following rotablation, a 3.50 x 38 synergy stent was deployed for treatment.Upon withdrawing the stent delivery system, the shaft broke inside the guide catheter.No patient complications were reported; however, the procedure was delayed.
Additional Manufacturer Narrative
The synergy ii us mr 3.50 x 38mm stent delivery system was returned for analysis.The stent was not returned as it was successfully implanted during the procedure.The balloon was returned in a deflated state.The distal balloon cone appears to be unfolded.A red blood like substance is visible inside the balloon cones and inflation lumen.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section found a shaft break 119.5cm distal to the distal end of strain relief.There were multiple shaft polymer extrusion kinks, and the shaft was stretched at the guidewire port.No other issues were identified during the product analysis.

• 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: 11306753
• Report Number: 2134265-2021-00915
• Device Sequence Number: 3286534
• Product Code: NIQ
• UDI-Device Identifier: 08714729840428
• UDI-Public: 08714729840428
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/16/2022
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0026425861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1