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

Model Number 10617

Device Problem Difficult to Remove (1528)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event.The event date was not provided.The first date of the month of the aware date was selected.

Event Description

It was reported that removal difficulty occurred.The target lesion was located in the left main artery.A 5.0 x 12 synergy drug-eluting stent was advanced for treatment.However, during procedure, it was noted that the stent balloon could not be withdrawn back into the guide catheter.The device together with the guidewire.The procedure was completed with the original device.There were no patient complications reported.

Manufacturer Narrative

B3:date of event updated to "(b)(6) 2020.".

Event Description

It was reported that removal difficulty occurred.The target lesion was located in the left main artery.A 5.0 x 12 synergy drug-eluting stent was advanced for treatment.However, during procedure, it was noted that the stent balloon could not be withdrawn back into the guide catheter.The device together with the guidewire.The procedure was completed with the original device.There were no patient complications reported.

Manufacturer Narrative

A synergy ii us mr 5.00 x 12mm stent delivery system was returned for analysis.The device returned without the stent attached and inside the customers hemostatic valve, guidecatheter and with the guidewire inserted but not exiting the distal tip.The balloon cones were reviewed.The distal end of the balloon was bunched at the distal end of the guide catheter.A visual examination of the bumper tip showed signs of damage.A visual and tactile examination of the hypotube found multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.The device was inflated to 16 atm as per instructions for use and the device deflated within 27 seconds using the inflation device.The device was withdrawn through the distal end of the guide-catheter following deflation.No other issues were identified during the product analysis.

Event Description

It was reported that removal difficulty occurred.The target lesion was located in the left main artery.A 5.0 x 12 synergy drug-eluting stent was advanced for treatment.However, during procedure, it was noted that the stent balloon could not be withdrawn back into the guide catheter.The device together with the guidewire.The procedure was completed with the original device.There were no patient complications reported.

• 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: 11012025
• MDR Text Key: 221539386
• Report Number: 2134265-2020-17788
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P150003/S039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2022
• Device Model Number: 10617
• Device Catalogue Number: 10617
• Device Lot Number: 0025358967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1