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

Model Number	H7493941808220
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the severely tortuous and mildly calcified left anterior descending artery (lad).A 2.25 x 8mm synergy xd drug-eluting stent (des) was prepared to be delivered.However, the shaft got kinked outside of the hemostasis valve.Upon continuous attempt to deliver the device, the proximal portion of delivery shaft broke off when trying to deliver around the hard bend.The stent and remaining shaft were removed with no other complications.The detached portion was simply pulled out and the procedure was completed with a non-boston scientific device.There were no patient complications reported.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the severely tortuous and mildly calcified left anterior descending artery (lad).A 2.25 x 8mm synergy xd drug-eluting stent (des) was prepared to be delivered.However, the shaft got kinked outside of the hemostasis valve.Upon continuous attempt to deliver the device, the proximal portion of delivery shaft broke off when trying to deliver around the hard bend.The stent and remaining shaft were removed with no other complications.The detached portion was simply pulled out and the procedure was completed with a non-boston scientific device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 2.25 x 8mm; stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent found no issues.The stent was securely crimped between both markerbands.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.The device was received in two sections as a result of a break in the hypotube.The break was located at 22.2cm distal from the strain relief.A visual, microscopic and tactile examination of the hypotube found multiple kinks along both sections of the hypotube.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16038234
• Report Number: 2124215-2022-54227
• Device Sequence Number: 7193544
• Product Code: NIQ
• UDI-Device Identifier: 08714729980704
• UDI-Public: 08714729980704
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 02/21/2023

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: 02/23/2024
• Device Model Number: H7493941808220
• Device Lot Number: 0028959327
• 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: 12/13/2022
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: MEDTRONIC 6F LAUNCHER; GUIDE CATHETER: MEDTRONIC 6F LAUNCHER
• Patient Sex: Unknown
• Patient Race: White