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

Model Number	H7493941832270
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred requiring additional intervention.The target lesion with in-stent restenosis was located in the mildly tortuous and calcified right coronary artery.Following pre-dilatation with a 2.5x20mm balloon catheter, a 2.75 x 32mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the middle of the shaft fractured.The device was removed by snaring, and the procedure was successfully completed with another stent.There were no patient complications nor injuries reported and the patient was fully recovered.
Event or Problem Description
It was reported that shaft break occurred requiring additional intervention.The target lesion with in-stent restenosis was located in the mildly tortuous and calcified right coronary artery.Following pre-dilatation with a 2.5x20mm balloon catheter, a 2.75 x 32mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the middle of the shaft fractured.The device was removed by snaring, and the procedure was successfully completed with another stent.There were no patient complications nor injuries reported and the patient was fully recovered.
Additional Manufacturer Narrative
The synergy xd mr us 2.75 x 32mm stent delivery system was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.The hypotube shaft identified a break at 75cm distal to the distal end of the strain relief.No issues were identified with the outer/mid-shaft section or the inner lumen of the device.There was no sign of damage, stretching or lifting of the stent struts.The stent was set between the proximal and distal markerbands and there was no sign of movement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and had not been subjected to positive pressure.The bumper tip showed no signs of distal tip damage.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17233475
• Report Number: 2124215-2023-32196
• Device Sequence Number: 7300094
• Product Code: NIQ
• UDI-Device Identifier: 08714729980926
• UDI-Public: 08714729980926
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/14/2024
• Device Model Number: H7493941832270
• Device Lot Number: 0029856979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male