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

Lot Number 0029694346

Device Problems Break (1069); Inflation Problem (1310)

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

Event Date 02/07/2024

Event Type  malfunction  

Event 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 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.

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
• 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: 18747362
• MDR Text Key: 336417763
• Report Number: 2124215-2024-09370
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729981091
• UDI-Public: 08714729981091
• 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: 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
• Device Operator: Health Professional
• Device Lot Number: 0029694346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2022
• 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