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

Model Number	10617
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in an ascending aortic arch.After a guide catheter was advanced, a 6f guidezilla ii guide catheter extension was advanced into the guide catheter.However, it got lodged or jammed and could not advanced further.The device was removed from the guide catheter and a non bsc guide extension catheter was advanced in the lesion.A 5.0x16mm synergy drug-eluting stent (des) was advanced and implanted in the lesion.A second 5.00 x 12mm synergy (des) was advanced for treatment; however, during advancing, the stent went up and around the ascending arch in the guide catheter and the hypotube was fractured.The procedure was completed with a non bsc device.No patient complications were reported.
Additional Manufacturer Narrative
Device is a combination product.The device was returned for analysis.A visual examination of the stent found no issues on the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set equidistant between the proximal and distal markerbands.The crimped stent od (outer diameter) was measured and was noted to be within specification.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded on the distal balloon cones and were not subjected to positive pressure.The tip was visually and microscopically examined and no signs of damage were noted.A visual and tactile examination found that the hypotube was broken at 17.3cm from the distal end of the strain relief.Multiple hypotube kinks were also noted along several locations of the hypotube shaft.This type of damage is consistent with excessive force being applied on the delivery system.A visual and tactile examination of the outer and mid shaft section and a tactile examination of the inner lumen found no issues with the extrusion shaft.No other issues were noted on the device.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in an ascending aortic arch.After a guide catheter was advanced, a 6f guidezilla ii guide catheter extension was advanced into the guide catheter.However, it got lodged or jammed and could not advanced further.The device was removed from the guide catheter and a non bsc guide extension catheter was advanced in the lesion.A 5.0x16mm synergy drug-eluting stent (des) was advanced and implanted in the lesion.A second 5.00 x 12mm synergy (des) was advanced for treatment; however, during advancing, the stent went up and around the ascending arch in the guide catheter and the hypotube was fractured.The procedure was completed with a non bsc device.No patient complications were reported.

• 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: 8437666
• Report Number: 2134265-2019-02771
• Device Sequence Number: 11211525
• Product Code: NIQ
• UDI-Device Identifier: 08714729973423
• UDI-Public: 08714729973423
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 04/22/2019

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: 11/04/2020
• Device Model Number: 10617
• Device Catalogue Number: 10617
• Device Lot Number: 0022901575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 03/30/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 04/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1