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

Model Number 10619

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: synergy ous mr 2.50 x 20 mm stent delivery system was returned for analysis without the stent.A review of the manufacturing stent profile data was performed and the stent outer diameter was within max crimped stent profile measurement.The balloon cones were reviewed, and signs of positive pressure applied to the cones were noted.Crimp markings are visible on the exposed balloon wall.A visual and tactile examination of the hypotube found multiple kinks along several locations of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section found a 2 mm long tear in the shaft polymer extrusion located at the guidewire exchange port.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 21sep2020.It was reported that crossing difficulties were encountered.The 85% stenosed target lesion was located in the right coronary artery.A 2.50 x 20 synergy drug-eluting stent was advanced but failed to cross the lesion.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.However, returned device analysis revealed a stent detachment.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10643928
• MDR Text Key: 210260441
• Report Number: 2134265-2020-13855
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2021
• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0024489973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR