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

Model Number 10623

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

A synergy ous mr 3.00 x 38 mm stent delivery system was returned for analysis.A visual examination of the stent found that the stent was damaged from mid-section of stent to the distal end, with stent struts lifted from crimped stent positions and misaligned.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 struts got caught in the calcification.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 tip showed signs of damage on the distal edges of the tip.Tip damage most likely occurred when the tip was pushed against a restriction.A visual and tactile examination of the hypotube found multiple kinks along 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 extrusion, mid-shaft section, and visual examination of the inner extrusion found no issue with the extrusion shaft.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 03oct2020.It was reported that crossing difficulties were encountered.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery.After the lesion was pre-dilated, a 3.00 x 38 synergy ii 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.However, returned device analysis revealed 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10730412
• MDR Text Key: 212862669
• Report Number: 2134265-2020-14717
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2020
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0024020342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2019
• 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: 70 YR