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

Lot Number	0029949070
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Reduced Blood Flow (4598)
Date of Event	07/05/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that removal difficulties occurred which resulted in myocardial infarction and patient death.The 70-80% stenosed target lesion was located in the non-tortuous and severely calcified mid circumflex artery.After the lesion was prepared using a 1.5 rota burr, the 3.50 x 20mm synergy xd drug-eluting stent was advanced and deployed at 16 atmospheres.However, there was an under expanded stent area and the distal end of the stent delivery system (sds) balloon appeared to be stuck in calcification.Multiple attempts were made to deflate the balloon over the course of 30-40 minutes.Reinflation and deflation could not be performed because the balloon would not inflate.An attempt was made to wire next to the balloon to release it from wherever it was stuck, and a surgeon was also consulted to provide help in removing the sds.In a final attempt to remove the balloon, the sds catheter broke, and the balloon remained inside the patient.The left circumflex shut down and myocardial infarction occurred.The patient died on the table.

• 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: 17399106
• Report Number: 2124215-2023-39643
• Device Sequence Number: 7571855
• Product Code: NIQ
• UDI-Device Identifier: 08714729981053
• UDI-Public: 08714729981053
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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
• Report Date (Section B): 07/26/2023

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: 08/01/2024
• Device Lot Number: 0029949070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2022
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 77 YR
• Patient Sex: Female