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

Model Number	10604
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via a voluntary medwatch (b)(4) that shaft break occurred.A 4.00 x 24 synergy drug-eluting stent was advanced for treatment.The synergy drug-eluting stent failed to cross the lesion.It was noted that the device was shredded in guide extension catheter.Both devices were removed and a new 6f guidezilla ii guide extension catheter and a new 4.5mm synergy stent was used.A 4.5x32mm synergy drug-eluting stent was selected for use.While inserting the stent over the guidewire into the guide catheter, it bent.The physician tried to straighten it and the catheter snapped in half.No patient complications were reported.
Event or Problem Description
It was reported via a voluntary medwatch (b)(4) that shaft break occurred.A 4.00 x 24 synergy drug-eluting stent was advanced for treatment.The synergy drug-eluting stent failed to cross the lesion.It was noted that the device was shredded in guide extension catheter.Both devices were removed and a new 6f guidezilla ii guide extension catheter and a new 4.5mm synergy stent was used.A 4.5x32mm synergy drug-eluting stent was selected for use.While inserting the stent over the guidewire into the guide catheter, it bent.The physician tried to straighten it and the catheter snapped in half.No patient complications were reported.It was further reported that the patient status was stable and was discharged home on the next day.

• 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: 12338032
• Report Number: 2134265-2021-10458
• Device Sequence Number: 14141627
• Product Code: NIQ
• UDI-Device Identifier: 08714729840251
• UDI-Public: 08714729840251
• Combination Product (Y/N): Y
• Initial Reporter State: MT
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

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: 10/29/2022
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0026333239
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 107