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

Lot Number 0029984291

Device Problems Device Dislodged or Dislocated (2923); Material Deformation (2976)

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

Event Date 12/29/2023

Event Type  Injury  

Event Description

It was reported that stent dislodgement occurred requiring additional intervention.The 90% stenosed target lesion was located in the moderately tortuous and heavily calcified right coronary artery.A 3.50 x 24mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the shaft of the delivery system was compromised and bent resulting to partially deployed the stent.During removal, it dislodged from the system losing the stent in the guide and sheath at the access site.The undeployed stent was removed, and the second stent was placed successfully.No patient complications were reported.

Manufacturer Narrative

D4: lot number: updated from 0031289131 to 0029984291.Synergy xd mr us 3.50 x 32mm stent delivery system was returned for analysis.The stent was not returned for analysis.A visual and tactile examination of the hypotube found no issues.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.The balloon cones were reviewed, and the crimp marks were visible.A review of the manufacturing stent profile data was performed and the stent outer diameter at the time of manufacture was within max crimped stent profile measurement as per specification.The bumper tip showed no signs of distal tip damage.The reported kinks were not identified during the analysis.No other device issues were identified during the returned product analysis.

Event Description

It was reported that stent dislodgement occurred requiring additional intervention.The 90% stenosed target lesion was located in the moderately tortuous and heavily calcified right coronary artery.A 3.50 x 24mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the shaft of the delivery system was compromised and bent resulting to partially deployed the stent.During removal, it dislodged from the system losing the stent in the guide and sheath at the access site.The undeployed stent was removed, and the second stent was placed successfully.No patient complications were reported.

• 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: 18635764
• MDR Text Key: 334466617
• Report Number: 2124215-2024-04205
• Device Sequence Number: 1
• Product Code: NIQ
• 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
• Report Date: 03/01/2024

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 Lot Number: 0029984291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2022
• 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