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

Model Number 10623

Device Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address 1: (b)(6).

Event Description

It was reported that stent damage occurred.The angulated target lesion was located in the moderately tortuous and severely calcified right coronary artery.A 3.50 x 38 synergy drug-eluting stent was advanced but resistance was encountered.When the device was removed, it was noted that the edge of the stent was damaged.No known patient complications nor injuries reported.

Event Description

It was reported that stent damage occurred.The angulated target lesion was located in the moderately tortuous and severely calcified right coronary artery.A 3.50 x 38 synergy drug-eluting stent was advanced but resistance was encountered.When the device was removed, it was noted that the edge of the stent was damaged.No known patient complications nor injuries reported.

Manufacturer Narrative

E1 initial reporter address 1: (b)(6).Device evaluated by mfr.: synergy ous mr 3.50 x 38 mm stent delivery system was returned for analysis.A visual examination of the stent found that the stent struts at the distal stent strut row were damaged with struts pulled proximally.The undamaged crimped stent outer diameter measured and the result was within maximum crimped stent profile measurement.Stent damage most likely occurred when the stent met resistance of a calcified lesion, the stent struts got caught in the calcification.The balloon cones were reviewed, and no issues were noted.Balloon cones shows signs of positive pressure having been applied.A visual and microscopic examination of the tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks on several locations of the hypotube shaft.This type of damage is consistent with excessive force that could have been applied to the delivery system.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues with the extrusion shaft.A recommended 0.014 inch test guidewire was loaded successfully.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: 10848240
• MDR Text Key: 216940762
• Report Number: 2134265-2020-15822
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2021
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0024672193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1