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

Model Number 10617

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2020

Event Type  malfunction  

Event 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.

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 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
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10987166
• MDR Text Key: 220917070
• Report Number: 2134265-2020-17308
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729973348
• UDI-Public: 08714729973348
• Combination Product (y/n): N
• PMA/PMN Number: P150003/S039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR