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

Model Number 10620

Device Problems Device Dislodged or Dislocated (2923); Material Deformation (2976)

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

Event Date 12/23/2023

Event Type  malfunction  

Manufacturer Narrative

A2: age at time of event: 18 years or older (b)(6).

Event Description

It was reported that stent dislodgement occurred.The 85% stenosed, 24mmx3.0mm, target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 3.00 x 24 synergy drug-eluting stent was advanced for treatment.However, during procedure, the stent had burr and moved from the balloon.The procedure was completed with another of same device.There were no patient complications reported, and the patient was stable post-procedure.

Manufacturer Narrative

A2: age at time of event: 18 years or older.E1: initial reporter facility name: (b)(6).E1: initial reporter phone: (b)(6).Device evaluated by mfr.: synergy ous mr 3.00 x 24mm stent delivery system was returned for analysis.Visual, tactile, microscopic and dimensional analysis was performed on the device.Visual and tactile examination of the stent noted the stent had been damaged, while microscopic examination confirmed stent damage with stretching visible along the length of the stent.Based on the extent of the stent damage it was not possible to measure the outer diameter of the crimped stent.The stent has been pulled proximally from the balloon and the distal edge of the stent is positioned over the proximal markerband.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.There are visible crimp marks present on the balloon.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.Bumper tip showed no signs of distal tip damage.

Event Description

It was reported that stent dislodgement occurred.The 85% stenosed, 24mmx3.0mm, target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 3.00 x 24 synergy drug-eluting stent was advanced for treatment.However, during procedure, the stent had burr and moved from the balloon.The procedure was completed with another of same device.There were no patient complications reported, and the patient was stable post-procedure.

• 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: 18530571
• MDR Text Key: 333132616
• Report Number: 2124215-2024-01836
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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: 02/26/2024

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 Model Number: 10620
• Device Catalogue Number: 10620
• Device Lot Number: 0030555793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2023
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 02/13/2024
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2022
• 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