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

Lot Number 0024998039

Device Problems Break (1069); Inflation Problem (1310)

Patient Problems Chest Pain (1776); Obstruction/Occlusion (2422)

Event Date 07/09/2020

Event Type  Injury  

Event Description

It was reported that shaft break, no flow, and chest pain occurred.The target lesion was located in a tortuous and moderately calcified left anterior descending artery.The lesion was pre-dilated and a guide extension catheter was used for stent delivery.A 2.50 x 38mm synergy xd drug-eluting stent (des) was deployed distally in the lesion with no issues reported.A 3.00 x 20mm synergy xd des was positioned proximal to the implanted stent, but when pressure was applied to the balloon, expansion occurred only in the front of the balloon.No flow and chest pain then occurred.Upon removal of the 3.00 x 20mm synergy xd, the shaft broke outside the patient.The procedure was completed with another device.

Manufacturer Narrative

Examination of the crimped stent via scope found that the stent struts at the most distal and most proximal stent strut rows had been lifted and flared outwards.This dog-boning shape is consistent with some pressure being applied to the delivery system.The stent outer diameter (od) of the undamaged and fully crimped mid-stent was 0.0395 inches.The od of distal flare was 0.0485 inches and the od of proximal flare was 0.0470 inches.The crimp stent manufacturing data of the complaint device was reviewed.The review showed that at during manufacture, the maximum crimped stent profile was measured at 0.0416 inches, within the maximum crimped stent profile measurement, demonstrating that the lifting of stent struts to 0.0485 inches and 0.0470 inches at distal and proximal ends of the stent occurred during device use.The balloon cones were reviewed via scope.The proximal balloon cone appeared slightly opened/unfolded consistent with slight pressure being applied to the device.There was no visible damage to or tears in the balloon material.A visual and tactile examination of the hypotube identified a hypotube break 629mm distal to the distal end of the strain relief with slight bending on both sides of the break and a hypotube kink 585mm distal to the distal end of the strain relief.Examination of the tip via scope found no damage to the tip.The shaft polymer extrusion including the distal and mid-shaft sections were examined via scope and tactile examination.No damage was noted.A red blood like substance noted in the mid-shaft inflation lumen was consistent with the shaft breaking inside of the guide catheter.Examination of the hub and strain relief via scope did not identify any issues.The device was successfully loaded onto a 0.014 inch guidewire.Due to the hypotube break a balloon inflation test could not be carried out per normal procedure of attaching inflation device to the synergy xd hub.An inflation aid was used to make a connection between the broken hypotube and inflation device; the inflation aid was attached directly onto the hypotube, onto the distal side of hypotube break and an encore inflation device was attached to inflation aid.The balloon was inflated to 16 atm with a glycerol-water solution.The balloon inflated successfully with no leaks/ruptures noted and the stent deployed, due to the red blood like substance in inflation lumen the inflated balloon contained what appeared to be blood.A vacuum was pulled, and the balloon deflated fully without issue in 8 seconds.Note encore inflation device verified before and after use.No other issues were identified during the product analysis.

Event Description

It was reported that shaft break, no flow, and chest pain occurred.The target lesion was located in a tortuous and moderately calcified left anterior descending artery.The lesion was pre-dilated and a guide extension catheter was used for stent delivery.A 2.50 x 38mm synergy xd drug-eluting stent (des) was deployed distally in the lesion with no issues reported.A 3.00 x 20mm synergy xd des was positioned proximal to the implanted stent, but when pressure was applied to the balloon, expansion occurred only in the front of the balloon.No flow and chest pain then occurred.Upon removal of the 3.00 x 20mm synergy xd, the shaft broke outside the patient.The procedure was completed with another device.Device analysis also revealed stent damage.

• Brand Name: SYNERGY XD
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10353217
• MDR Text Key: 201422034
• Report Number: 2134265-2020-09977
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2021
• Device Lot Number: 0024998039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER:ASAHI INTEC HYPERION JL3.5; GUIDE CATHETER:ASAHI INTEC HYPERION JL3.5; GUIDE EXTENSION:TELESCOPE; GUIDE EXTENSION:TELESCOPE; GUIDEWIRE:SION BLUE; GUIDEWIRE:SION BLUE
• Patient Outcome(s): Required Intervention