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

Model Number	H7493941816350
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first day of the month of bsc aware date since event date not provided.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the mildly tortuous and non-calcified left anterior descending artery.A 3.50 x 16mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the stent catheter broke.The broken part was removed manually.The procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient status was stable.
Additional Manufacturer Narrative
B3 date of event: used the first day of the month of bsc aware date since event date not provided.A synergy xd mr us 3.50 x 16mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The stent od (outer diameter) was measured 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 and a hypotube break 24 cm distal to the strain relief.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 shaft break occurred.The target lesion was located in the mildly tortuous and non-calcified left anterior descending artery.A 3.50 x 16mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the stent catheter broke.The broken part was removed manually.The procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient status was stable.It was further reported that the target lesion was moderately calcified rather than non-calcified as was previously reported.

• 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: 11787456
• Report Number: 2134265-2021-05749
• Device Sequence Number: 19707954
• Product Code: NIQ
• UDI-Device Identifier: 08714729981046
• UDI-Public: 08714729981046
• Combination Product (Y/N): Y
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: 01/04/2023
• Device Model Number: H7493941816350
• Device Lot Number: 0026609251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1