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

Model Number 10632

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 08/25/2020

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.During preparation of a 2.50 x 48 synergy drug-eluting stent, it was noted that the stent was flared.The procedure was completed with a different device.No patient complications were reported and the patient status was stable.

Event Description

It was reported that stent damage occurred.During preparation of a 2.50 x 48 synergy drug-eluting stent, it was noted that the stent was flared.The procedure was completed with a different device.No patient complications were reported and the patient status was stable.

Manufacturer Narrative

Device evaluation by mfr.: a synergy ous mr 2.50 x 48mm stent delivery system was returned for analysis.An examination of the crimped stent identified proximal stent damage with the stent struts lifted from the crimped position.The undamaged crimped stent outer diameter was measured and the result was within max crimped stent profile measurement.The balloon was 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 tactile examination of the hypotube found multiple hypotube kinks and a kink in the hypotube laser cut region 330mm proximal to the distal end of the distal tip.An examination of the shaft polymer extrusion found no issues.An examination of the tip found no issues.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: 10519031
• MDR Text Key: 206501673
• Report Number: 2134265-2020-12626
• 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: 11/11/2020

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: 04/16/2022
• Device Model Number: 10632
• Device Catalogue Number: 10632
• Device Lot Number: 0025470588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1