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

Lot Number	0030944954
Medical Device Problem Codes	Material Rupture (1546); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent dislodged inside the patient requiring additional intervention.The target lesion was located in the middle of the left anterior descending (lad) artery.A 3.00 x 8mm synergy xd drug-eluting stent was used for treatment.Prior to inflation, the stent came off the balloon.When the balloon was inflated to securely deploy the stent inside another stent, the balloon ruptured.A new stent was inserted to complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 3.00 x 8mm stent delivery system, catheter was returned for analysis.Visual, tactile, microscopic and functional analysis was performed on the device.Visual and tactile inspection identified no issues with the hypotube shaft, no issues were identified with the outer / mid-shaft sections or the inner lumen of the device, and no stent was attached to the balloon.Microscopic analysis revealed the balloon was subjected to positive pressure and the bumper tip showed no signs of distal tip damage.Functional analysis was performed, the device was attached to an inflation unit and the balloon was inflated to its rated burst pressure per the instructions for use.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that the stent dislodged inside the patient requiring additional intervention.The target lesion was located in the middle of the left anterior descending (lad) artery.A 3.00 x 8mm synergy xd drug-eluting stent was used for treatment.Prior to inflation, the stent came off the balloon.When the balloon was inflated to securely deploy the stent inside another stent, the balloon ruptured.A new stent was inserted to complete the procedure.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: 18681731
• Report Number: 2124215-2024-04069
• Device Sequence Number: 6155869
• Product Code: NIQ
• UDI-Device Identifier: 08714729980940
• UDI-Public: 08714729980940
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 04/01/2024

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: 01/22/2025
• Device Lot Number: 0030944954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2023
• 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