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

Lot Number 0030214117

Device Problems Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

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

Event Date 12/27/2023

Event Type  malfunction  

Event Description

It was reported that stent dislodgement occurred.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending.A 3.50 x 12mm synergy xd drug-eluting stent was advanced for treatment.However, during insertion of the device the stent dislodged inside the patient.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 12mm stent delivery system (sds); catheter number was returned for analysis.A visual and tactile examination of the hypotube found multiple kinks along the shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.No stent was returned for analysis.The balloon cones were reviewed, and the balloon was in a deflated state.Based on microscopic analysis, no stent was returned for analysis.A review of the manufacturing stent profile data was performed and the stent od at the time of manufactured.The balloon cones were reviewed, and the balloon was in a deflated state.A visual and tactile examination of the hypotube found multiple kinks along the shaft.Bumper tip showed no signs of distal tip damage.

• 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: 18727411
• MDR Text Key: 336192443
• Report Number: 2124215-2024-08075
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0030214117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2022
• 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