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

Lot Number 0028915062

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/19/2024

Event Type  Injury  

Event Description

It was reported that stent dislodgement occurred, requiring additional intervention.The stenosed target lesion was about 60 to 70%, located in the mildly tortuous and moderately calcified left anterior descending artery.A 3.00 x 28mm synergy drug-eluting stent was selected for treatment.However, during the procedure, the stent came off the balloon and stayed inside the heart at a curve before the treatment area.Subsequently, the patient was sent for emergency coronary artery bypass surgery.The device still remains in the patient, and no attempts were made to retrieve the stent.No further issues were reported, and the patient was well-conditioned.

• 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: 18875951
• MDR Text Key: 337339446
• Report Number: 2124215-2024-12169
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729980995
• UDI-Public: 08714729980995
• 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: 03/11/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2024
• Device Lot Number: 0028915062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• 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): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male