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

Lot Number	0031185876
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Ventricular Fibrillation (2130); Foreign Body In Patient (2687)
Date of Event	04/12/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that stent dislodgement and patient death occurred.The patient presented with st elevation myocardial infarction and coronary artery disease in the left anterior descending artery (lad).Vascular access was obtained via the right groin.Imaging showed severely calcified coronary arteries and the 80-90% stenosed mid lad was identified as the culprit vessel.A previous stent was present in the proximal lad.Pre-dilation of the mid lad was performed using a 2.50 x 12 mm nc emerge balloon.A 2.50 x 32 mm synergy xd stent was advanced to the mid lad but because the stent was too long, it was removed undeployed.When another picture was taken with contrast however, it was apparent the undeployed stent was still in the proximal lad.The physician thought the stent caught on calcium in the vessel and came off the delivery system during retrieval.Rewiring of the lad to attempt to crush the dislodged stent was unsuccessful and an attempt to implant a left ventricular assist device (lvad) was also unsuccessful due to the heavily calcified vessels; several stents were present in the iliac vessel making it extremely difficult to advance the lvad through the left groin.During the procedure, the patient experienced ventricular fibrillation.Surgery was called for bypass surgery, but the patient did not make it and died in the catheter lab.

• 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: 19235060
• Report Number: 2124215-2024-26958
• Device Sequence Number: 6882707
• Product Code: NIQ
• UDI-Device Identifier: 08714729980841
• UDI-Public: 08714729980841
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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
• Report Date (Section B): 05/02/2024

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: 02/27/2025
• Device Lot Number: 0031185876
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2023
• 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: Death
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Race: White