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

Lot Number	0031135037
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the right coronary artery.A 2.75 x 12mm synergy xd drug-eluting stent (des) was selected for treatment.However, the proximal shaft broke before entering the patient's body.The procedure was completed with a new synergy xd des.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the right coronary artery.A 2.75 x 12mm synergy xd drug-eluting stent (des) was selected for treatment.However, the proximal shaft broke before entering the patient's body.The procedure was completed with a new synergy xd des.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy xd mr us 2.75 x 12mm was returned to the complaint investigation site (cis).A visual, tactile and microscopic examination identified multiple hypotube kinks and a break at 21.5cm distal to the distal end of the strain relief were identified along the shaft of the device.No issues identified with the outer/mid-shaft sections or the inner lumen of the device.A visual, tactile and microscopic examination identified there was no sign of damage, stretching or lifting of the stent struts.A microscopic examination of balloon cones was reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.An examination of the proximal and distal markerband identified no issues.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: 19152967
• Report Number: 2124215-2024-24158
• Device Sequence Number: 12887035
• Product Code: NIQ
• UDI-Device Identifier: 08714729980872
• UDI-Public: 08714729980872
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 06/05/2024

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: 02/12/2025
• Device Lot Number: 0031135037
• 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: 04/09/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2023
• 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