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

Model Number 10619

Device Problem Material Deformation (2976)

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

Event Date 10/22/2020

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.The 80% stenosed, 20mm x 3.0 target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery (lad).A 3.00 x 20 synergy drug-eluting stent was advanced for treatment.However, the proximal of the stent was rubbed against the distal end of lad and it was noted that the stent struts were lifted.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Event Description

It was reported that stent damage occurred.The 80% stenosed, 20mm x 3.0 target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery (lad).A 3.00 x 20 synergy drug-eluting stent was advanced for treatment.However, the proximal of the stent was rubbed against the distal end of lad and it was noted that the stent struts were lifted.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: the synergy ous mr 3.00 x 20mm stent delivery system was returned for analysis.An examination (visual and via scope) of the crimped stent found stent damage.Stent struts in the very proximal region lifted and pulled distally.The undamaged crimped stent outer diameter was measured using snap gauge and the result is within max 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 showed no signs of tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks along several locations of the hypotube shaft.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.No other issues were identified during the product analysis.

• 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: 11090968
• MDR Text Key: 224396840
• Report Number: 2134265-2020-18546
• 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: 02/04/2021

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: 01/06/2022
• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0025027309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 89