MAUDE Adverse Event Report: MEDTRONIC IRELAND INTEGRITY RX; STENT, CORONARY

Catalog Number INT25022X

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 11/05/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information: the device was not moved or repositioned in the lesion prior to the burst.The balloon burst on the first inflation.It was reported there was a gradual drop in pressure.The procedure was completed using two resolute onyx (2.5 x 22mm and 3.0 x 22mm) devices to cover the vessel from the left main to the left anterior descending artery.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

During a procedure an integrity rx coronary bare metal stent was used to treat a non calcified, mildly tortuous lesion exhibiting 70% stenosis in the mid left anterior descending (lad) artery.There was no damage noted to the packaging and there were no issues when removing the device from the hoop.The device was inspected with no issues noted.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered.Excessive force was not used during delivery.It was reported that the balloon burst during stent deployment at 3atm.There was no patient injury reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: an image shows a lesion in the lad.An image shows a balloon delivered to the lesion in the mid lad.A second wire is visible in the diagonal branching off the lad, suggesting buddy wire technique was used.An image shows a contrast image following pre-dilation.A stent is delivered to the lesion in the lad.An attempt is made to deploy the stent; however, the balloon appears to have partially inflated and contrast is visible flowing through the vessel distal to where the stent is positioned.This indicates that the balloon has ruptured.The stent appears to have partially inflated and dislodged from the delivery system.An image shows slow flow through the distal lad.An image shows the lad and the diagonal vessels have been rewired.A balloon is delivered to the left main.An image shows kissing balloon technique is performed to crush the dislodged stent.An image shows the dislodged stent has been crushed against the vessel wall of the lad.An image shows a balloon delivered and the lesion is pre-dilated.A contrast shot following pre dilation.A contrast image shows narrowing of the mid-lad.A stent is delivered to the lesion site in the mid lad.The stent is deployed at the lesion in the mid lad.An image shows the deployed stent.The vessel is pre-dilated, proximal to the deployed stent.An image shows a stent is delivered inside the body of the deployed stent.The balloon is inflated, and the stent expanded.An image shows the stent deployed.An image shows the stent post dilated.A contrast image showing good flow through the treated vessels.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation summary the device returned with blood visible in the balloon and inflation lumen.The balloon failed negative prep.On pressurisation of the device, liquid was observed exiting the balloon distal cone.The balloon failed to maintain pressure.Upon visual inspection of the device, there was a short longitudinal tear on the balloon material immediately proximal to the balloon distal cone.The balloon material was jagged and uneven at the tear site.No other damage evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTEGRITY RX
• Type of Device: STENT, CORONARY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9289533
• MDR Text Key: 170792492
• Report Number: 9612164-2019-04681
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P030009
• 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,Followup,Followup,Followup,Followup
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2022
• Device Catalogue Number: INT25022X
• Device Lot Number: 0009456034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2018
• 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
• Patient Outcome(s): Required Intervention