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

Lot Number	0029942056
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break and removal difficulties occurred.A percutaneous coronary intervention (pci) procedure was performed.The stenosed target lesion was located in the severely tortuous and severely calcified coronary artery.A 4.00 x 38mm synergy xd drug-eluting stent (des) was advanced for treatment.However, during delivery through a 6f non-boston scientific guide extension catheter, the stent failed to cross the entire lesion.The physician attempted to pull the device out, but the shaft broke with the stent, balloon, and part of the shaft still entrapped in the coronary artery.Multiple unsuccessful snaring attempts were made, so the patient was sent for open-heart surgery to retrieve the broken device.
Event or Problem Description
It was reported that shaft break and removal difficulties occurred.A percutaneous coronary intervention (pci) procedure was performed.The stenosed target lesion was located in the severely tortuous and severely calcified coronary artery.A 4.00 x 38mm synergy xd drug-eluting stent (des) was advanced for treatment.However, during delivery through a 6f non-boston scientific guide extension catheter, the stent failed to cross the entire lesion.The physician attempted to pull the device out, but the shaft broke with the stent, balloon, and part of the shaft still entrapped in the coronary artery.Multiple unsuccessful snaring attempts were made, so the patient was sent for open-heart surgery to retrieve the broken device.
Additional Manufacturer Narrative
The synergy xd mr us 4.00 x 38mm stent delivery system was returned for analysis.Visual and tactile inspection showed multiple hypotube kinks along the shaft of the device.A break was also noted at the mid-shaft near the guidewire exchange port with the distal part of the device (polymer extrusion, stent, balloon cones and tip profile) not returned.There was 221cm of the device returned, from the strain relief to the break at the guidewire exchange port.

• 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: 17692486
• Report Number: 2124215-2023-45087
• Device Sequence Number: 6378675
• Product Code: NIQ
• UDI-Device Identifier: 08714729981176
• UDI-Public: 08714729981176
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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): 10/09/2023

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: 08/02/2024
• Device Lot Number: 0029942056
• 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: 08/15/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2022
• 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: 6F GUIDELINER GUIDE EXTENSION CATHETER; 6F GUIDELINER GUIDE EXTENSION CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown