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

Catalog Number RONYX30030X

Device Problems Failure to Advance (2524); Device Dislodged or Dislocated (2923); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problems Patient Problem/Medical Problem (2688); No Information (3190)

Event Date 06/18/2018

Event Type  Injury  

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 one resolute onyx drug eluting stent to treat a moderately tortuous lesion located in the mid right coronary artery.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues identified.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device.It was reported that while passing through the guide towards the lesion the stent did not pass through.Some force was applied and while taking back, the device dislodged.Then dislodged stent was removed with surgery.Patient status post-procedure is alive with no injury.

Manufacturer Narrative

Additional information received reported that the lesion exhibited minimal stenosis and calcification.No difficulties were noted when removing the protective sheath.Negative prep was not performed.The inflation device remained on neutral pressure during delivery of the device.The stent was removed at the femoral level by making a small incision to remove it.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

Evaluation summary: a kink was evident on the hypotube 12.1cm distal to the strain relief.The stent was not present on the balloon and did return for analysis.Crimp impressions were visible on the exposed balloon surface.The balloon folds remained intact.The dislodged stent returned stretched, bunched and deformed.The inner lumen patency could not be verified with a 0.015 inch mandrel most likely due to hardened blood.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,ie
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway,ie
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7689074
• MDR Text Key: 114007897
• Report Number: 9612164-2018-01739
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P160043
• 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
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2020
• Device Catalogue Number: RONYX30030X
• Device Lot Number: 0008997000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• 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: 07/20/2018; 08/08/2018; 09/21/2018
• Supplement Dates FDA Received: 08/14/2018; 10/03/2018; 10/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2018
• 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