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

Catalog Number RONYX25015UX

Device Problems Inflation Problem (1310); Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A resolute onyx device was intended to be used to treat a moderately tortuous, non-calcified lesion with 70% stenosis in the proximal lad.There was no damage noted to the device packaging.There were no issues when removing the device from the hoop.The device was inspected with no issues.Negative prep was not performed.The lesion was not pre-dilated.The device did not pass through a previously-deployed stent.No resistance was encountered when advancing the device.Excessive force was not used during delivery.It is reported that the tech heard the release of air coming from the hub when drawing negative.An attempt was made to reach nominal pressure when the device was in the patient, but a leak at the luer/hub was noted.Upon inability to inflate the balloon, the entire stent device was safely removed and placed on the sterile prep table.The device was replaced by another resolute onyx of the same lot.No patient injury is reported.

Manufacturer Narrative

Additional information reported that after positioning the stent at the lesion, the scrub tech drew negative.It was at that moment that the tech heard air seep out of the hub.The stent and balloon was removed effortlessly and without any risk to the patient.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.

Manufacturer Narrative

Correction to aware date/date mfr rec for previously submitted additional information.The correct aware date for report # 96121 64-2018-01744 is the (b)(6) 2018.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.

Manufacturer Narrative

Device evaluation: kinks were evident on the hypotube from 51.5cm to 136cm proximal to the strain relief.The device returned with a detachment on the hypotube immediately distal to the strain relief.The hypotube material was oval and jagged on both sides of the detachment site.A make shift leur was attached to the hypotube at the detachment site, the balloon inflated at 12atm and the stent deployed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX 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: 7689291
• MDR Text Key: 114556168
• Report Number: 9612164-2018-01744
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556805
• UDI-Public: 00643169556805
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2020
• Device Catalogue Number: RONYX25015UX
• Device Lot Number: 0008988041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2018
• Initial Date FDA Received: 07/16/2018
• Supplement Dates Manufacturer Received: 07/16/2018; 08/08/2018; 09/21/2018; 09/21/2018; 11/27/2018
• Supplement Dates FDA Received: 08/13/2018; 10/03/2018; 10/19/2018; 11/22/2018; 11/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2018
• 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 Age: 56 YR