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

Model Number	H7493941824400
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the highly calcified right coronary artery.A 4.00 x 24mm synergy xd drug-eluting stent was advanced for treatment, however, during procedure while trying to cross the lesion the shaft break.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the highly calcified right coronary artery.A 4.00 x 24mm synergy xd drug-eluting stent was advanced for treatment, however, during procedure while trying to cross the lesion the shaft break.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.
Additional Manufacturer Narrative
Updated b5: describe event or problem.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the highly calcified right coronary artery.A 4.00 x 24mm synergy xd drug-eluting stent was advanced for treatment, however, during procedure while trying to cross the lesion the shaft break.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.It was further that the lesion was severely calcified and moderately tortuous.A resistance was felt while advancing and the shaft break halfway.The device was completely removed from the patient's body by pulling out with hands.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the highly calcified right coronary artery.A 4.00 x 24mm synergy xd drug-eluting stent was advanced for treatment, however, during procedure while trying to cross the lesion the shaft break.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.It was further that the lesion was severely calcified and moderately tortuous.A resistance was felt while advancing and the shaft break halfway.The device was completely removed from the patient's body by pulling out with hands.
Additional Manufacturer Narrative
A synergy xd mr us 4.00 x 24mm stent delivery system 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 using snap gauge 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 and a break 23.8 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.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13530274
• Report Number: 2134265-2022-01575
• Device Sequence Number: 14739498
• Product Code: NIQ
• UDI-Device Identifier: 08714729981145
• UDI-Public: 08714729981145
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2022

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: 07/15/2023
• Device Model Number: H7493941824400
• Device Lot Number: 0027748412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2022
• Supplement Date Received by Manufacturer: 02/02/2022; 02/24/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 02/17/2022; 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Unknown