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

Lot Number 0027114450

Device Problem Entrapment of Device (1212)

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

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event: used the first day of the month of aware date, as event date was not provided.

Event Description

It was reported that device entrapment occurred.The 90% stenosed target lesion was located in a moderately tortuous and moderately calcified vessel.A 3.50 x 28mm synergy xd drug eluting stent was advanced for treatment.The device was dilated three times at nominal pressure during stent placement.However, during the removal of the stent delivery system, the non-boston scientific (bsc) guidewire got stuck in wire lumen.The non-bsc guidewire and stent delivery system were removed from the patient's body together, and the procedure was completed with a different device.There were no patient complications nor injuries reported.

Manufacturer Narrative

Device evaluated by mfr.: synergy xd mr ous 3.50 x 28mm stent delivery system was returned for analysis.The stent was deployed from the balloon and was not received for analysis.An examination of the balloon identified contrast media inside the balloon.This indicates that the balloon was subjected to positive pressure.The balloon cones were reviewed, and no issues were noted.No tears or holes were noted in the balloon material.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks.A visual and microscopic examination of the outer and inner or wire lumen and mid-shaft section found no issues along the shaft polymer extrusion.Using a recommended 0.014 inch size guidewire, the guidewire was inserted through the tip and wire lumen with no resistance noted.The guidewire was removed with no resistance.D6a - implant date: used the first day of the month of aware date, as event date was not provided.B3 - date of event: used the first day of the month of aware date, as event date was not provided.

Event Description

It was reported that device entrapment occurred.The 90% stenosed target lesion was located in a moderately tortuous and moderately calcified vessel.A 3.50 x 28mm synergy xd drug eluting stent was advanced for treatment.The device was dilated three times at nominal pressure during stent placement.However, during the removal of the stent delivery system, the non-boston scientific (bsc) guidewire got stuck in wire lumen.The non-bsc guidewire and stent delivery system were removed from the patient's body together, and the procedure was completed with a different device.There were no patient complications nor injuries reported.It was further reported that the device entrapment occurred after the stent had been implanted.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16418778
• MDR Text Key: 309996247
• Report Number: 2124215-2023-05018
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

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: 03/30/2023
• Device Lot Number: 0027114450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2023
• Initial Date FDA Received: 02/22/2023
• Supplement Dates Manufacturer Received: 03/29/2023
• Supplement Dates FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2021
• 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