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

Model Number H7493941820270

Device Problems Break (1069); Inflation Problem (1310); Material Separation (1562); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

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

Event Date 03/30/2023

Event Type  malfunction  

Event Description

It was reported that stent dislodgement occurred.The patient underwent percutaneous coronary intervention (pci).A 2.75 x 20mm synergy xd drug-eluting stent was advanced for treatment but failed to cross the lesion.It was noted that the stent balloon did not expand, and the stent came off the balloon inside the guide catheter.No patient complications were reported.

Manufacturer Narrative

E1: initial reporter phone number: (b)(6).H6: device codes - corrected from a051201 device dislodged or dislocated to a0401 break.H6: device codes- removed a0413 material separation and a1406 inflation problem.

Event Description

It was reported that stent dislodgement occurred.The patient underwent percutaneous coronary intervention (pci).A 2.75 x 20mm synergy xd was advanced but failed to cross lesion.However, the balloon did not expand; the stent came off the balloon and was dislodged in the guider.No patient complications were reported.It was further reported that the stent came off the delivery system inside the guide catheter prior to deployment.The balloon and stent broke off from the distal shaft and were detached from the delivery system.The device was removed as a whole unit and the procedure was completed with a different device.

Manufacturer Narrative

B5: describe event or problem updated.

Event Description

It was reported that stent dislodgement occurred.The patient underwent percutaneous coronary intervention (pci).A 2.75 x 20mm synergy xd was advanced but failed to cross lesion.However, the balloon did not expand; the stent came off the balloon and was dislodged in the guider.No patient complications were reported.It was further reported that the balloon and stent came off the delivery system inside the guide catheter.The device was removed with the guide catheter as a whole unit and the procedure was completed with a different device.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16756088
• MDR Text Key: 313452029
• Report Number: 2124215-2023-16742
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729980896
• UDI-Public: 08714729980896
• 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,Followup,Followup
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493941820270
• Device Lot Number: 0030258815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2022
• 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