MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE INTEGRITY RX; STENT, CORONARY, DRUG-ELUTING

Model Number RSINT27522X

Device Problems Fracture (1260); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During the procedure, an attempt was made to use three resolute integrity rx coronary drug eluting stents to treat a moderately tortuous and severely calcified lesion in the proximal rca exhibiting 99% stenosis.There were no abnormalities in relation to the anatomy.There was no damage noted to packaging.There were no issues removing the devices from the hoop.The devices were inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was pre-dilated.The devices did not pass through a previously deployed stent.Resistance was encountered when advancing the devices.Excessive force was used during delivery.It was reported that the first resolute integrity stent (lot 0008513508) failed to cross the lesion due to calcification and stent strut damage occurred.It was also reported that the shaft of the stent was broken.The lesion was further predilated and an attempt was made to pass a second resolute integrity stent (lot 0008912986) however this was unsuccessful and the stent deformed in vivo during positioning/advancement, and the shaft of the stent was broken/fractured.Pre dilation was again repeated and a third resolute integrity stent (lot 0008912986) deformed in vivo during positioning/advancement and the shaft of the stent broke and the stent failed to cross the lesion.The case was stopped and postponed for another date.It is reported that the three devices became kinked while inside the patient, and the shaft breaks occurred outside the patient, while attempting to correct the kinks.The physician commented that the events were due to use of the devices in difficult lesion morphology/anatomy.No patient injury was reported.

Manufacturer Narrative

An image shows the lesion as reported by the account.Pre dilation of the lesion is performed.A stent is introduced and an attempt is made to deliver the stent to the lesion.The stent is removed and the lesion is further pre dilated.A second stent is introduced and an attempt is made to deliver the stent to the lesion.The stent is withdrawn after failed delivery.It is not possible to see stent strut deformation in the image.The lesion is further pre dilated.A third stent is introduced and an attempt made to deliver the stent to the lesion.The stent was not deployed as the following image shows no stent present.A contrast image of the lesion is taken showing stenosis present.The lesion is further dilated and the procedure is completed as no further images were provided.The images show the inability to deliver the stents but do not show the reported stent deformation.Product analysis: kinks were evident on the hypotube 22.5cm and 24.9cm distal to the strain relief.The stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 8th and 9th distal stent wraps with struts raised and stretched.No deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.The device returned with a detachment on the hypotube 73.5cm distal to the strain relief.The hypotube material was oval and jagged on both sides of the detachment site.A kink was evident on the hypotube 2.8cm proximal to the detachment site.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• 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: 7850089
• MDR Text Key: 119344564
• Report Number: 9612164-2018-02312
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P110013
• 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
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2020
• Device Model Number: RSINT27522X
• Device Catalogue Number: RSINT27522X
• Device Lot Number: 0008912986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2017
• 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
• Patient Weight: 75