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

Model Number	10602
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Patient Involvement (2645); Insufficient Information (4580)
Date of Event	11/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 3.00 x 16 synergy ii drug-eluting stent was prepped for use.However, the mid shaft was found damaged and broke inside the guide before entering the patient's body.The stent did not dislodge into the patient's body.The device was removed and the procedure was completed with another of the same device.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that shaft break occurred.A 3.00 x 16 synergy ii drug-eluting stent was prepped for use.However, the mid shaft was found damaged and broke inside the guide before entering the patient's body.The stent did not dislodge into the patient's body.The device was removed and the procedure was completed with another of the same device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 3.00 x 16mm stent delivery system, catheter was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The crimped stent outer diameter was measured and the result is within maximum crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found hypotube break 540mm distal to strain relief as well as multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.

• 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: 10971670
• Report Number: 2134265-2020-17031
• Device Sequence Number: 19907341
• Product Code: NIQ
• UDI-Device Identifier: 08714729840114
• UDI-Public: 08714729840114
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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: 06/16/2022
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0025621944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1