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

Model Number 10621

Device Problems Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 02/24/2022

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.The target lesion was located in the left coronary artery (lca).A 3.00 x 28 synergy drug-eluting stent was selected for use in a percutaneous coronary intervention (pci).However, during preparation, it was noted that the tip of the stent was kinked.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.

Event Description

It was reported that stent damage occurred.The target lesion was located in the left coronary artery (lca).A 3.00 x 28 synergy drug-eluting stent was selected for use in a percutaneous coronary intervention (pci).However, during preparation, it was noted that the tip of the stent was kinked.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.It was further reported that only the tip of the device was damaged.

Manufacturer Narrative

B5-describe event or problem has been updated.H6 device codes initially reported as a0406-material deformation, updated to a04-material integrity problem.

Manufacturer Narrative

Synergy ous mr 3.00 x 28mm stent delivery system was returned for analysis.A visual examination of the stent found signs of stent damage.Stent damage was noted in the mid-section of the stent.Struts were found to be misaligned.The undamaged crimped stent outer diameter was measured and the result was within maximum 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 identified no issues.A visual and tactile examination of the hypotube identified 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.

Event Description

It was reported that stent damage occurred.The target lesion was located in the left coronary artery (lca).A 3.00 x 28 synergy drug-eluting stent was selected for use in a percutaneous coronary intervention (pci).However, during preparation, it was noted that the tip of the stent was kinked.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.It was further reported that only the tip of the device was damaged.

• Brand Name: SYNERGY
• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13769910
• MDR Text Key: 287201140
• Report Number: 2134265-2022-02937
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2023
• Device Model Number: 10621
• Device Catalogue Number: 10621
• Device Lot Number: 0027006146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2021
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 67 KG