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

Model Number 10617

Device Problem Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2020

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.The 3.0x12mm target lesion was located in the left circumflex (lcx) artery.A 3.00x12mm synergy drug-eluting stent was advanced for treatment.However, it was noted that the distal end of the stent struts were lifted up due to the scratch with the proximal end of the lcx.The procedure was completed with another of the same device.There were no patient complications and the patient was stable.

Manufacturer Narrative

Device evaluated by mfr.: synergy ous mr 3.00 x 12 mm stent delivery system was returned for analysis.A visual examination of the stent identified that the crimped stent was flared at the proximal and distal ends of the stent.The undamaged crimped stent 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 tip showed no signs of damage.A visual and tactile examination of the hypotube found no issues with the delivery system.A visual and tactile examination of the outer and mid-shaft section and visual examination of the inner lumen found no issues with the extrusion shaft.No other issues were identified during the product analysis.

Event Description

It was reported that stent damage occurred.The 3.0x12mm target lesion was located in the left circumflex (lcx) artery.A 3.00x12mm synergy drug-eluting stent was advanced for treatment.However, it was noted that the distal end of the stent stent struts were lifted up due to the scratch with the proximal end of the lcx.The procedure was completed with another of the same device.There were no patient complications and the patient was stable.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11171804
• MDR Text Key: 226858794
• Report Number: 2134265-2021-00312
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

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 Expiration Date: 01/19/2022
• Device Model Number: 10617
• Device Catalogue Number: 10617
• Device Lot Number: 0025102592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 02/16/2021
• Supplement Dates FDA Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 89