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

Model Number	H7493941812400
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 patient presented with peripheral vascular disease and underwent percutaneous coronary intervention.The target lesion was located in the severely tortuous vessel below the knee.A 4.00 x 12mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the shaft broke and had to be snared.Subsequently, a 3.5 x 12 synergy xd drug-eluting stent was deployed.However, upon removal, the shaft broke.The device was removed with no patient complications.
Additional Manufacturer Narrative
B5 - updated describe event or problem.Device evaluated by mfr.: synergy xd mr us 4.00 x 12mm was returned for analysis.As the manifold section of the device was not returned with the device, it is not possible to determine the catheter batch.The stent was detached/deployed from the balloon and was not returned for analysis.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, microscopic and tactile examination of the hypotube found multiple kinks.A break existed in the hypotube.The break was located at 103cm proximal from distal tip of device.The proximal section of the break including the hub section of the device was not returned for analysis.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.
Event or Problem Description
It was reported that shaft break occurred requiring additional intervention.The patient presented with peripheral vascular disease and underwent percutaneous coronary intervention.The target lesion was located in the severely tortuous vessel below the knee.A 4.00 x 12mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the shaft broke and had to be snared.Subsequently, a 3.5 x 12 synergy xd drug-eluting stent was deployed.However, upon removal, the shaft broke.The device was removed with no patient complications.It was further reported that there was no stent dislodgement occurred and the second stent was deployed successfully.The device retrieved and no fragments left inside patient body.

• 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: 16216177
• Report Number: 2124215-2023-01069
• Device Sequence Number: 7518430
• Product Code: NIQ
• UDI-Device Identifier: 08714729981114
• UDI-Public: 08714729981114
• 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): 02/28/2023

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: 09/20/2023
• Device Model Number: H7493941812400
• Device Lot Number: 0028130805
• 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: 01/06/2023
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown