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

Model Number	H7493941812350
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred requiring additional intervention.The target lesion was located in a severely tortuous vessel below the knee.A 4.00 x 12mm synergy xd drug-eluting stent (des) was advanced for treatment.In an attempt to implant the stent, the shaft was broken and snaring was used to remove the device.The physician again advanced another 3.50 x 12mm synergy xd des and was able to be delivered successfully which completed the procedure.However, upon removal, the shaft was broken.No device fragments were left inside the patient's body.There were no patient complications reported.
Additional Manufacturer Narrative
Synergy xd 3.50/12mm stent delivery system was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal 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.A visual and tactile examination of the hypotube found a shaft break at 26cm 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 requiring additional intervention.The target lesion was located in a severely tortuous vessel below the knee.A 4.00 x 12mm synergy xd drug-eluting stent (des) was advanced for treatment.In an attempt to implant the stent, the shaft was broken and snaring was used to remove the device.The physician again advanced another 3.50 x 12mm synergy xd des and was able to be delivered successfully which completed the procedure.However, upon removal, the shaft was broken.No device fragments were left inside the patient's body.There were no patient complications reported.

• 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: 16216197
• Report Number: 2124215-2023-01558
• Device Sequence Number: 5991151
• Product Code: NIQ
• UDI-Device Identifier: 08714729981039
• UDI-Public: 08714729981039
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 03/17/2023

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: 07/26/2024
• Device Model Number: H7493941812350
• Device Lot Number: 0029931639
• 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: 01/06/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2022
• 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 Sex: Unknown