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

Model Number	H7493941832250
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred requiring additional intervention.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.The 90% stenosed target lesion was located in the non-tortuous and moderately calcified right coronary artery to posterior descending artery.A 2.50 x 32mm synergy xd drug-eluting stent was advanced for treatment.However, during withdrawal, the distal catheter shaft broke off in the patient.Physician tried to snare the broken piece from the patient, but it was unsuccessful.Patient was transferred to another hospital and was sent for coronary artery bypass graft (cabg) to retrieve the detached device from the patient.No patient complications were reported and the patient was fully recovered.
Event or Problem Description
It was reported that shaft break occurred requiring additional intervention.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.The 90% stenosed target lesion was located in the non-tortuous and moderately calcified right coronary artery to posterior descending artery.A 2.50 x 32mm synergy xd drug-eluting stent was advanced for treatment.However, during withdrawal, the distal catheter shaft broke off in the patient.Physician tried to snare the broken piece from the patient, but it was unsuccessful.Patient was transferred to another hospital and was sent for coronary artery bypass graft (cabg) to retrieve the detached device from the patient.No patient complications were reported and the patient was fully recovered.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 2.50 x 32mm was returned for analysis.A microscopic examination of the distal extrusion identified a break in the midshaft extrusion located at 122cm distal from the strain relief.The extrusion exhibited signs of stretching at the break site.The distal section of the break including the balloon and tip section of the device was not returned for analysis.Further analysis confirmed multiple kinking along the length of the hypotube.

• 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: 16714015
• Report Number: 2124215-2023-16201
• Device Sequence Number: 16546588
• Product Code: NIQ
• UDI-Device Identifier: 08714729980841
• UDI-Public: 08714729980841
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• 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): 07/14/2023

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: 07/07/2023
• Device Model Number: H7493941832250
• Device Lot Number: 0027688503
• 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: 03/31/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2021
• 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