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

Model Number 10617

Device Problems Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/09/2024

Event Type  Injury  

Event Description

It was reported that stent dislodgement occurred.The patient presented with myocardial infarction.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery (lad).A long non-boston scientific stent was deployed from the mid lad to distal lad.A 3.00 x 16 synergy was advanced for treatment.While positioning the stent for deployment, it was observed that the stent was stuck in the long stent and dislodged from the delivery system.The physician decided to deploy the dislodged stent within the long stent.A 3.00 x 12 mm synergy was also selected for treatment of the calcified left circumflex artery (lcx), but the failed to cross.The physician removed the stent and dilated the lesion properly.The stent was reintroduced, and when attempting to deploy in the lcx it was observed that the stent was dislodged and could not be found.A 2.75 x 16 mm synergy and 2.75 x 12 synergy were then deployed in lad and lcx and the procedure was completed successfully.No patient complications were reported, and the patient was fine post-procedure.

• Brand Name: SYNERGY
• 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: 18629762
• MDR Text Key: 334421798
• Report Number: 2124215-2024-01849
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10617
• Device Catalogue Number: 10617
• Device Lot Number: 0030725509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2022
• 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: 58 YR
• Patient Sex: Male
• Patient Race: Asian