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

Lot Number	0029967767
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 2.25 x 28mm synergy xd drug-eluting stent was advanced for treatment.However, during introduction, the device broke midshaft outside of the patient.The device was removed, and the procedure was completed with another of same device.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.A 2.25 x 28mm synergy xd drug-eluting stent was advanced for treatment.However, during introduction, the device broke midshaft outside of the patient.The device was removed, and the procedure was completed with another of same device.No patient complications were reported.It was further reported that the target lesion was located in the left anterior descending artery.
Additional Manufacturer Narrative
B5.Describe event or problem updated.Device evaluated by mfr: synergy xd mr us 2.25 x 28mm was returned for analysis.A visual, tactile, microscopic and dimensional testing were performed on the device.Visual examination identified the stent had damage at the proximal section.A visual and tactile examination of the hypotube found multiple kinks and a break in the shaft at 24cm distal to the distal end of the strain relief.No issues identified with the outer / mid-shaft sections or the inner lumen of the device.The microscopic examination of the crimped stent via scope found evidence of stent damage with stent struts lifted at the proximal section.No signs of movement, stent was set between the proximal and distal markerbands.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Bumper tip showed no signs of distal tip damage.The undamaged crimped stent od (outer diameter) was measured by snap gauge and the result is within max crimped stent profile measurement.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that shaft break occurred.A 2.25 x 28mm synergy xd drug-eluting stent was advanced for treatment.However, during introduction, the device broke midshaft outside of the patient.The device was removed, and the procedure was completed with another of same device.No patient complications were reported.It was further reported that the target lesion was located in the left anterior descending artery.

• 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: 17889708
• Report Number: 2124215-2023-55054
• Device Sequence Number: 12594387
• Product Code: NIQ
• UDI-Device Identifier: 08714729980759
• UDI-Public: 08714729980759
• 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,Followup
• Report Date (Section B): 11/16/2023

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: 08/10/2024
• Device Lot Number: 0029967767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 10/13/2023; 11/14/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 10/19/2023; 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2022
• 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
• Patient Sex: Unknown