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

Model Number	10601
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 2.25 x 12 synergy ii drug-eluting stent was advanced for treatment.However, during the procedure, the middle of the shaft broke.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 2.25 x 12 stent delivery system was returned for analysis.Examination of the crimped stent via scope identified no damage.A section of the crimped stent outer diameter was measured and the result was within max crimped stent profile.The balloon cones were reviewed via scope, and no issues were noted.The balloon wings were tightly wrapped and evenly folded.The balloon had not been subjected to positive pressure.A visual and tactile examination of the hypotube identified a shaft break at 66.5cm distal from the distal end of the strain relief.Also multiple hypotube kinks were observed.Examination of the tip via scope found no damage to the tip.The shaft polymer extrusion including the distal and mid-shaft sections were examined via scope and a tactile examination was performed.No issues were noted.
Event or Problem Description
It was reported that shaft break occurred.A 2.25 x 12 synergy ii drug-eluting stent was advanced for treatment.However, during the procedure, the middle of the shaft broke.No patient complications were reported.It was further reported that the fracture occurred outside the patient's body and the device was simply pulled from the guide catheter.The procedure was completed with another of same device and the patient status was stable.
Event or Problem Description
It was reported that shaft break occurred.A 2.25 x 12 synergy ii drug-eluting stent was advanced for treatment.However, during the procedure, the middle of the shaft broke.No patient complications were reported.It was further reported that the fracture occurred outside the patient's body and the device was simply pulled from the guide catheter.The procedure was completed with another of same device and the patient status was stable.

• 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: 12353599
• Report Number: 2134265-2021-10559
• Device Sequence Number: 4535249
• Product Code: NIQ
• UDI-Device Identifier: 08714729840022
• UDI-Public: 08714729840022
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2021

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: 03/29/2023
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0027094055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 08/24/2021; 09/15/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 09/12/2021; 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1