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

Model Number 10621

Device Problems Break (1069); Failure to Advance (2524)

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

Event Date 12/13/2023

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.The 85% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.75 x 28mm synergy drug-eluting stent was advanced for treatment.However, the shaft of the stent broke 15-20cm from the hub towards proximal end while crossing the lesion.The physician simply pulled the device and another 2.75x38 synergy was placed to cover the lesion and the procedure was completed.There were no patient complications reported.

Event Description

It was reported that shaft break occurred.The 85% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.75 x 28mm synergy drug-eluting stent was advanced for treatment.However, the shaft of the stent broke 15-20cm from the hub towards proximal end while crossing the lesion.The physician simply pulled the device and another 2.75x38 synergy was placed to cover the lesion and the procedure was completed.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr.: synergy ous mr 2.75 x 28mm stent delivery system was returned to the complaint investigation site.Visual and tactile inspection revealed that there were no issues identified with the hypotube shaft.A visual inspection of the outer and inner lumen and tactile examination of the mid-shaft section found no issues.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.Stent positioning revealed no signs of movement, stent was set between the proximal and distal markerbands.No issues identified with the hypotube shaft.Bumper tip showed no signs of distal tip damage.No device issues were identified during returned product analysis.

• Brand Name: SYNERGY
• 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: 18550913
• MDR Text Key: 333321419
• Report Number: 2124215-2024-01979
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10621
• Device Catalogue Number: 10621
• Device Lot Number: 0030843246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2023
• 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: 60 YR
• Patient Sex: Male
• Patient Race: Asian