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

Lot Number	0033291989
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment and shaft break occurred.The 99% stenosed target lesion was located in a mildly tortuous and mildly calcified left coronary artery.A 2.50 x 12 mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the device was unable to cross the lesion.Following this failure, the stent was retracted but became stuck with the guidewire.Both the wire and the stent were removed together out from the body.Attempts to withdraw the wire from the stent catheter were unsuccessful.As the stent catheter was withdrawn, the distal portion about 25-30 cm back from the tip of the catheter was separated from the main body of the stent.The procedure was completed using a compliant balloon.No complications were reported for the patient.
Additional Manufacturer Narrative
The device was returned for analysis.A visual and tactile examination identified no kinks or damages along the entire length of the hypotube.The device was received in two sections due to a break in the midshaft.The break was located approximately 9cm from the port exchange.A visual and tactile examination of the distal extrusion identified that the extrusion was stretched and kinked.A microscopic examination of the distal extrusion identified that the extrusion was stretched and kinked.The break in the midshaft extrusion is consistent with excessive tensile force having been applied to the midshaft.A microscopic examination of the crimped stent identified no damages.The stent was securely positioned between the proximal and distal markerbands.A microscopic examination of the balloon material identified no damages.The balloon was tightly folded and did not appear to have been subjected to any positive pressures.A microscopic examination of the tip identified no damages.The crimped stent od (outer diameter) was measured and the result was within maximum crimped stent profile measurement.
Event or Problem Description
It was reported that catheter entrapment and shaft break occurred.The 99% stenosed target lesion was located in a mildly tortuous and mildly calcified left coronary artery.A 2.50 x 12 mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the device was unable to cross the lesion.Following this failure, the stent was retracted but became stuck with the guidewire.Both the wire and the stent were removed together out from the body.Attempts to withdraw the wire from the stent catheter were unsuccessful.As the stent catheter was withdrawn, the distal portion about 25-30 cm back from the tip of the catheter was separated from the main body of the stent.The procedure was completed using a compliant balloon.No complications were reported for the patient.

• 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: 20271096
• Report Number: 2124215-2024-58024
• Device Sequence Number: 17026999
• Product Code: NIQ
• UDI-Device Identifier: 08714729980797
• UDI-Public: 08714729980797
• Combination Product (Y/N): Y
• Initial Reporter State: UT
• 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): 11/06/2024

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: 01/09/2026
• Device Lot Number: 0033291989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• 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