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

Model Number	H7493941816400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the non-tortuous and moderately calcified ostial left anterior descending artery.A 4.00 x 16mm synergy xd drug-eluting stent was advanced to treat the lesion.The stent was deployed and inflated at 16 atmospheres with no issues.However, upon deflation of the balloon delivery system, the distal shaft of the stent at roughly 10 inches from the blue/white hub broke.Both the broken piece near the hub and the stent delivery system were manually pulled and were able to be easily removed from patient's body.The procedure was completed.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 4.00 x 16mm stent delivery system catheter was returned for analysis.The stent was deployed successfully and remains within the patient.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 damage.A visual and tactile examination of the hypotube found a shaft break at 21cm distal to the distal end of the strain relief and multiple kinks.A visual and tactile examination of the outer and mid-shaft section found no issues.No other issues noted with device.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the non-tortuous and moderately calcified ostial left anterior descending artery.A 4.00 x 16mm synergy xd drug-eluting stent was advanced to treat the lesion.The stent was deployed and inflated at 16 atmospheres with no issues.However, upon deflation of the balloon delivery system, the distal shaft of the stent at roughly 10 inches from the blue/white hub broke.Both the broken piece near the hub and the stent delivery system were manually pulled and were able to be easily removed from patient's body.The procedure was completed.There were no patient complications reported.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16452327
• Report Number: 2124215-2023-09165
• Device Sequence Number: 12145208
• Product Code: NIQ
• UDI-Device Identifier: 08714729981121
• UDI-Public: 08714729981121
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 04/23/2023

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: 11/29/2023
• Device Model Number: H7493941816400
• Device Lot Number: 0028509211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 04/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2021
• 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 Sex: Unknown