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

Model Number 10623

Device Problem Material Deformation (2976)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2020

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.A 2.25 x 38mm synergy ii drug eluting stent was selected for use.However, after the device was unpacked, it was noticed that the appearance of the stent was not smooth.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.

Manufacturer Narrative

Device evaluated by mfr: synergy ous mr 2.25 x 38mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found evidence of damage.The struts on the proximal end lifted and pulled distally.The undamaged crimped stent outer diameter was measured using snap gauge 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 examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.

Event Description

It was reported that stent damage occurred.The 80% stenosed target lesion was located in the proximal end of the left anterior descending artery.A 2.25 x 38mm synergy ii drug eluting stent was selected for use.However, after the device was unpacked, it was noticed that the appearance of the stent was not smooth.The procedure was completed with another of same device.There were no patient complications reported and patient status 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: 11217653
• MDR Text Key: 228420783
• Report Number: 2134265-2021-00246
• 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: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0025010542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 75