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

Model Number	10619
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft fracture occurred.The target lesion was located in a calcified artery.A 5.00 x 20 synergy ii drug-eluting stent was advanced to treat the lesion.However, the device got stuck and fractured.The device was removed and the procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was stable.
Event or Problem Description
It was reported that a shaft fracture occurred.The target lesion was located in a calcified artery.A 5.00 x 20 synergy ii drug-eluting stent was advanced to treat the lesion.However, the device got stuck and fractured.The device was removed and the procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy ii us mr 5.00 x 20 stent delivery system was returned for analysis.A visual examination of the stent found stent damage.Stent struts from the proximal region were lifted.The undamaged stent od (outer diameter) was measured using snap gauge and the result was 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 and microscopic examination of the bumper tip showed signs of tip damage.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.A recommended 0.014 was loaded without issue.No other issues were identified during the product analysis.

• 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: 10938127
• Report Number: 2134265-2020-16709
• Device Sequence Number: 16941404
• Product Code: NIQ
• UDI-Device Identifier: 08714729973447
• UDI-Public: 08714729973447
• Combination Product (Y/N): N
• Initial Reporter Country: RQ
• 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): 01/27/2021

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: 02/19/2022
• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0025272363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1