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

Lot Number 0029949070

Device Problems Break (1069); Difficult to Remove (1528); Failure to Deflate (4060)

Patient Problem Myocardial Infarction (1969)

Event Date 07/05/2023

Event Type  Death  

Event 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
• Type of Device: 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
• MDR Text Key: 319800814
• Report Number: 2124215-2023-39643
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729981053
• UDI-Public: 08714729981053
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0029949070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 77 YR
• Patient Sex: Female