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

Lot Number	0029694346
Medical Device Problem Codes	Break (1069); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the mildly tortuous and moderately calcified coronary artery.A 3.50 x 38mm synergy xd drug eluting stent was advanced for treatment.However, during deployment, the stent was not inflated, and physician felt pressure under his fingers.The physician decided to remove the stent delivery system (sds) from the body to inspect, but the back portion of the sds was fractured at about 8 to 10 inches from the hub where the inflation unit was attached.The device was pulled out and completely removed from the guide catheter and the patient's body.The procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the mildly tortuous and moderately calcified coronary artery.A 3.50 x 38mm synergy xd drug-eluting stent was advanced for treatment.However, during deployment, the stent was not inflated, and physician felt pressure under his fingers.The physician decided to remove the stent delivery system (sds) from the body to inspect, but the back portion of the sds was fractured at about 8 to 10 inches from the hub where the inflation unit was attached.The device was pulled out and completely removed from the guide catheter and the patient's body.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 3.50 x 38mm stent delivery system was returned for analysis.Visual and tactile inspection found multiple kinks on the hypotube shaft.A break was noted to be 22.6cm distal to the distal end of the strain relief.No issues identified with the outer / mid-shaft sections or the inner lumen of the device.Microscopic analysis revealed that there was no sign of damage, stretching or lifting of the stent struts.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.No issues were noted with the bumper tip.The device was attached to an encore and the balloon inflated with no issues.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: 18747362
• Report Number: 2124215-2024-09370
• Device Sequence Number: 20410409
• Product Code: NIQ
• UDI-Device Identifier: 08714729981091
• UDI-Public: 08714729981091
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/20/2024
• Device Lot Number: 0029694346
• 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: 02/07/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2022
• 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
• Patient Sex: Unknown