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

Model Number	10606
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	09/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent fracture occurred.The target lesion was located in the moderately calcified left main into the left anterior descending artery.A 3.00 x 32 synergy drug eluting stent was advanced for treatment and successfully deployed.However, after intravascular ultrasound was used together with an enhance stent visualization tool, it was noted that the stent was fractured.Subsequently, a second layer of stent was implanted to cover the fracture and the procedure was completed.There were no patient complications reported.
Event or Problem Description
It was reported that stent fracture occurred.The target lesion was located in the moderately calcified left main into the left anterior descending artery.A 3.00 x 32 synergy drug eluting stent was advanced for treatment and successfully deployed.However, after intravascular ultrasound was used together with an enhance stent visualization tool, it was noted that the stent was fractured.Subsequently, a second layer of stent was implanted to cover the fracture and the procedure was completed.There were no patient complications reported.
Additional Manufacturer Narrative
A review of the media provided by the site could not identify the alleged stent fracture.A gap which could indicate strut displacement was noted in the proximal to mid stent region and this might have appeared to the physician as stent fracture.The displaced struts visible in the photo review most likely represent a conformation of the stent to the fibro-calcific lesions in the distal section of the vessel anatomy allowed by the stent 4-connector proximal and 2-connector throughout.The coplanar view of the stent could lead to the assumption that there was a stent fracture when in fact what was being seen was two strut connectors on the same plane on view; this would be consistent with the stent image reviewed where struts are displaced in a v shape and connected in a central point.

• 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: 10627969
• Report Number: 2134265-2020-12953
• Device Sequence Number: 3205554
• Product Code: NIQ
• UDI-Device Identifier: 08714729840350
• UDI-Public: 08714729840350
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 11/03/2020

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: 12/17/2021
• Device Model Number: 10606
• Device Catalogue Number: 10606
• Device Lot Number: 0024976109
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention