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

Model Number	H7493941838350
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.As a 3.50 x 38mm synergy xd drug eluting stent was being inserted, the shaft broke.The device was removed and the procedure completed with another device.There were no patient complications.
Event or Problem Description
It was reported that a shaft break occurred.As a 3.50 x 38mm synergy xd drug eluting stent was being inserted, the shaft broke.The device was removed and the procedure completed with another device.There were no patient complications.
Additional Manufacturer Narrative
The synergy xd mr us 3.50 x 38 mm stent delivery system (sds) was returned for analysis.Examination of the crimped stent via scope found no issues with 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 between the proximal and distal marker bands.The crimped stent od (outer diameter) was measured 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 no signs of distal tip damage.A visual and tactile examination of the hypotube shaft found a hypotube break at 21.3 cm distal to distal end of strain relief and kinks were also noted along several locations of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues with the extrusion shaft.No other issues were identified during analysis.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11980218
• Report Number: 2134265-2021-07549
• Device Sequence Number: 19748039
• Product Code: NIQ
• UDI-Device Identifier: 08714729981091
• UDI-Public: 08714729981091
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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): 07/08/2021

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: 09/28/2022
• Device Model Number: H7493941838350
• Device Lot Number: 0026141009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1