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

Model Number	10605
Medical Device Problem Codes	Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: synergy ii us mr 2.25 x 28mm stent delivery system was returned for analysis.The device was returned without the stent.The balloon was reviewed, and issues were noted.No stent was attached to the balloon and the balloon appeared to be in a deflated state.A visual and microscopic examination of the bumper tip showed no issues.A visual and tactile examination of the hypotube found no issues.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.An 0.014 inch guidewire, verified with snap gauge, loaded successfully through the distal end of the tip and exited at the exchange port without issue.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 13-nov-2020.It was reported that advancing difficulty and shaft damage occurred.The target lesion was located in the moderately tortuous and moderately calcified vessel.After the lesion was pre-dilated, a 2.25 x 28 synergy ii drug-eluting stent was selected for treatment but the physician felt unusual resistance during delivery.Upon inspection, the shaft looked strained or stretched.The procedure was completed with another of the same device.There were no patient complications reported.However, returned device analysis revealed stent detachment.

• 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: 10941641
• Report Number: 2134265-2020-16578
• Device Sequence Number: 2419022
• Product Code: NIQ
• UDI-Device Identifier: 08714729840268
• UDI-Public: 08714729840268
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• 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
• Report Date (Section B): 12/03/2020

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: 01/21/2022
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0025136952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 12/03/2020
• Patient Sequence Number: 1