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

Model Number 10617

Device Problem Difficult to Advance (2920)

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

Event Date 05/17/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: a synergy ous mr 3.00 x 12mm stent delivery system (sds) was returned for analysis.Visual, tactile, microscopic, dimensional and functional analysis was performed on the device.Visual examination identified stent damage along the entire length of the stent.A stent od reading could not be obtained.A review of the manufacturing stent profile data was performed and the stent od at the time of manufacture was 0.0403 inches which is within specification.Microscopic analysis of the stent identified stent struts pulled distally and bunched at the distal section.There were signs of movement, with the stent moved over the distal 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.Bumper tip showed no signs of distal tip damage.No issues identified with the hypotube shaft.No issues identified with the outer / mid-shaft sections or the inner lumen of the device.The device was successfully tracked over a recommended 0.014 inch guidewire with no issues.

Event Description

Reportable based on device analysis completed on 31aug2023.It was reported that crossing difficulties were encountered.The target lesion was located in the long and diffused distal left anterior descending artery with more than 95% proximal calcification.A 3.00 x 12mm synergy drug-eluting stent was introduced but failed to advance.The procedure was completed with another stent.No patient complications were reported.However, returned device analysis revealed that the stent had moved over the distal markerband.

• 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: 17810526
• MDR Text Key: 324173277
• Report Number: 2124215-2023-48230
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 10617
• Device Catalogue Number: 10617
• Device Lot Number: 0027464788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2021
• 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: 76 YR
• Patient Sex: Male
• Patient Race: Asian