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

Model Number	10604
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: (b)(6) 2021 was used since procedure date was not provided.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary artery.A 3.50 x 24 synergy drug-eluting stent was selected for use.When the physician loaded the stent onto the wire, the shaft broke.The procedure was completed with different device.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary artery.A 3.50 x 24 synergy drug-eluting stent was selected for use.When the physician loaded the stent onto the wire, the shaft broke.The procedure was completed with different device.No patient complications were reported.
Additional Manufacturer Narrative
(b3) date of event: (b)(6) 2021 was used since procedure date was not provided.Device evaluated by mfr.: synergy ii 3.50 x 24 mm 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 within max crimped stent profile measurement.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 65cm distal from the distal end of the strain relief.Also a hypotube kink was observed 3cm proximal to the break site.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.

• 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: 12239952
• Report Number: 2134265-2021-09679
• Device Sequence Number: 14478434
• Product Code: NIQ
• UDI-Device Identifier: 08714729840244
• UDI-Public: 08714729840244
• Combination Product (Y/N): Y
• Initial Reporter State: NE
• 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
• Report Date (Section B): 09/20/2021

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: 01/18/2023
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0026701556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1