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

Lot Number	0033005682
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent fractured which resulted to additional intervention.The target lesion was located in the left main coronary artery.Following pre-dilatation, a 3.50 x 16mm synergy xd drug eluting stent was advanced for treatment, but it would not cross the lesion.Upon removal, the stent delivery system (sds) broke in half leaving part of it inside the patient.A snare was used to remove the portion of the sds out of the body.The procedure was completed with a different device.There were no patient complications reported.
Event or Problem Description
It was reported that stent fractured which resulted to additional intervention.The target lesion was located in the left main coronary artery.Following pre-dilatation, a 3.50 x 16mm synergy xd drug eluting stent was advanced for treatment, but it would not cross the lesion.Upon removal, the stent delivery system (sds) broke in half leaving part of it inside the patient.A snare was used to remove the portion of the sds out of the body.The procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 3.50 x 16mm stent delivery system (sds) was returned for analysis.Visual inspection identified that the stent had been detached from the delivery system and not returned.A visual, tactile and microscopic examination of the hypotube shaft identified a break at 35.5cm distal to the distal end of the strain relief.Multiple hypotube kinks were also noted.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.Microscopic analysis revealed that the balloon cones had no issues.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.The bumper tip showed no signs of distal tip damage.Dimensional testing revealed that the device was returned without the stent attached.The stent outer diameter at the time of manufacturing was within maximum crimped stent profile measurement.No other device issues were identified during returned product analysis.

• 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: 19243586
• Report Number: 2124215-2024-24605
• Device Sequence Number: 7430291
• Product Code: NIQ
• UDI-Device Identifier: 08714729981046
• UDI-Public: 08714729981046
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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): 06/19/2024

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: 11/21/2025
• Device Lot Number: 0033005682
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2023
• 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