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

Catalog Number RONYX30012UX

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 06/11/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

One resolute onyx drug eluting stent was intended to be used to treat a non-tortuous and moderately calcified lesion with 80% stenosis in the mid rca.There was no damage noted to the device packaging.There were no issues removing the device from the hoop.The device was not inspected.Negative prep was performed with no issues.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that stent dislodgement occurred during an attempted deployment.An angioplasty of the distal rca was performed prior to the stent dislodgement.The stent was not removed.No patient injury is reported.

Manufacturer Narrative

No difficulties noted when removing the protective sheath.The inflation device remain on neutral pressure during delivery of the device.An attempt was made to snare the dislodged stent but it was unsuccessful.The stent was lost in the patient anatomy.The angioplasty of the distal rca had no effect on the dislodgement of the stent.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

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: 7669082
• MDR Text Key: 113631421
• Report Number: 9612164-2018-01659
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556973
• UDI-Public: 00643169556973
• 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
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2020
• Device Catalogue Number: RONYX30012UX
• Device Lot Number: 0008954928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2018
• Date Device Manufactured: 01/16/2018
• 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
• Patient Age: 58 YR
• Patient Weight: 97