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

Lot Number 0029012509

Device Problem Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2022

Event Type  malfunction  

Event Description

It was reported the stent was entrapped on the guidewire.A percutaneous coronary intervention (pci) was performed on a distal right coronary artery (rca).A 2.25 x 24 mm synergy xd stent was advanced to the target lesion, but resistance occurred.It was not possible to advance the stent through the lesion.An attempt to remove the stent was made, but resistance occurred.The stent device had locked onto the guidewire.The device was removed and the procedure was completed with a non boston scientific device.No patient complications resulted in relation to this event, and the patient was reported to be fine.

Event Description

It was reported the stent was entrapped on the guidewire.A percutaneous coronary intervention (pci) was performed on a distal right coronary artery (rca).A 2.25 x 24 mm synergy xd stent was advanced to the target lesion, but resistance occurred.It was not possible to advance the stent through the lesion.An attempt to remove the stent was made, but resistance occurred.The stent device had locked onto the guidewire.The device was removed and the procedure was completed with a non boston scientific device.No patient complications resulted in relation to this event, and the patient was reported to be fine.It was further reported that the less than 50% stenosed target lesion was located in the calcified but excentric right coronary artery (rca) 2, after genius superius.The lesion was prepared with a (nc) balloon and intravascular ultrasound (ivus) confirmed the excentric calcification.No further patient complications were reported in relation to this event.

Manufacturer Narrative

Additional information: added to b5.

• Brand Name: SYNERGY XD
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15402402
• MDR Text Key: 299695938
• Report Number: 2124215-2022-35352
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Lot Number: 0029012509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 09/12/2022
• Supplement Dates Manufacturer Received: 09/07/2022
• Supplement Dates FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• 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