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

Model Number	10601
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred and the procedure was cancelled.The greater than 80% stenosed target lesion was located in the very tortuous and severely calcified ostial circumflex.A 3.00 x 12mm synergy ii drug-eluting stent was advanced for treatment.However, the device could not cross the lesion and it was observed that the mid part of the stent strut was deformed after trying to cross the calcified lesion.The device was removed from the patient's body.The procedure was cancelled.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 3.00 x 12mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage.Stent struts in the mid-section were lifted from the crimped profile.The undamaged stent outer diameter was measured and the result was within max 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 and microscopic examination of the bumper tip showed no signs of distal tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.No other issues were identified during analysis.
Event or Problem Description
It was reported that stent damage occurred and the procedure was cancelled.The >80% stenosed target lesion was located in the very tortuous and severely calcified ostial circumflex.A 3.00 x 12mm synergy ii drug-eluting stent was advanced for treatment.However, the device could not cross the lesion and it was observed that the mid part of the stent strut was deformed after trying to cross the calcified lesion.The device was removed from the patient's body.The procedure was cancelled.No patient complications were reported.

• 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: 12135612
• Report Number: 2134265-2021-08701
• Device Sequence Number: 19846596
• Product Code: NIQ
• UDI-Device Identifier: 08714729840053
• UDI-Public: 08714729840053
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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: 07/08/2022
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0025729958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR