MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT

Model Number	10617
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent fracture occurred.A 4.50 x 12 synergy ii drug-eluting stent was advanced for treatment.However, the stent strut were fractured and broke into two pieces.The procedure was completed with a second stent.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 4.50 x 12 mm was returned for analysis without the delivery system.A visual examination of the returned stent found that it was dislodged from the delivery system and damaged on its entire length with strut rows expanded and stretched.An examination under microscope of the stent could not find evidence of any broken struts/connectors.The balloon could not be reviewed as it was not returned.The tip of the device could not be reviewed as it was not returned.The hypotube shaft could not be reviewed as it was not returned.The shaft polymer extrusion could not be reviewed as it was not returned.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent fracture occurred.A 4.50 x 12 synergy ii drug-eluting stent was advanced for treatment.However, the stent strut were fractured and broke into two pieces.The procedure was completed with a second stent.There were no patient complications nor injuries reported.

• Brand Name: SYNERGY
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10987166
• Report Number: 2134265-2020-17308
• Device Sequence Number: 716177
• Product Code: NIQ
• UDI-Device Identifier: 08714729973348
• UDI-Public: 08714729973348
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P150003/S039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2021

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: 01/22/2021
• Device Model Number: 10617
• Device Catalogue Number: 10617
• Device Lot Number: 0023256778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR