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

Lot Number	0029984291
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2124215-2024-04205
• Device Sequence Number: 7954731
• Product Code: NIQ
• UDI-Device Identifier: 08714729981084
• UDI-Public: 08714729981084
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/03/2024
• Device Lot Number: 0029984291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown