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

Model Number 10623

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: synergy ous mr 2.50 x 38 mm stent delivery system was returned for analysis.A visual examination of the stent found that on the stent struts were pulled distally and lifted on the 3 most proximal stent rows.The undamaged crimped stent outer diameter 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 and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks along several locations of the hypotube shaft.A hypotube break at 275 mm distal from the distal end of strain relief and multiple kinks/partial breaks in the hypotube laser-cut region of the hypotube shaft were also noted.This type of damage is consistent with excessive force that could have been applied on the delivery system.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues with the extrusion shaft.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 14-feb-2019.It was reported that insertion difficulties were encountered.A 2.50x38 synergy drug-eluting stent was selected for use.However, it was noted that there was difficulty in inserting the device through the guide catheter starting from the hypotube.No known patient complications were reported.However, returned device analysis revealed hypotube break and stent damage.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8405219
• MDR Text Key: 138360334
• Report Number: 2134265-2019-02173
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2019

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: 12/22/2019
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0022315479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2019
• Initial Date FDA Received: 03/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2018
• 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