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

Lot Number 0028100388

Device Problems Contamination (1120); Device Dislodged or Dislocated (2923)

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

Event Date 01/19/2023

Event Type  malfunction  

Event Description

It was reported that stent dislodgement and device contamination occurred.The 82% stenosed target lesion was located in the severely calcified proximal left anterior descending artery.A 1.20mm x 8mm emerge push balloon catheter was advanced for pre-dilation.The device failed to cross the lesion and was detached outside the patient's body.A 4.50 x 12mm synergy megatron drug-eluting stent failed due to contamination and the stent dislodged outside of the patient's body.Another of same device was used to complete the procedure.No patient complications were reported, and the patient condition was stable.

Event Description

It was reported that stent dislodgement and device contamination occurred.The 82% stenosed target lesion was located in the severely calcified proximal left anterior descending artery.A 1.20mm x 8mm emerge push balloon catheter was advanced for pre-dilation.The device failed to cross the lesion and was detached outside the patient's body.A 4.50 x 12mm synergy megatron drug-eluting stent failed due to contamination and the stent dislodged outside of the patient's body.Another of same device was used to complete the procedure.No patient complications were reported, and the patient condition was stable.

Manufacturer Narrative

Device evaluated by mfr.: synergy megatron 4.50 x 12mm stent delivery system was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The stent outer diameter was measured and the result was within max crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of distal tip damage.A visual and tactile examination of the hypotube shaft 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.No issues were identified during analysis.

• Brand Name: SYNERGY MEGATRON
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16343211
• MDR Text Key: 309275751
• Report Number: 2124215-2023-03154
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2023
• Device Lot Number: 0028100388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2021
• 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
• Patient Age: 68 YR
• Patient Sex: Male