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

Catalog Number RONYX40038X

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a procedure an attempt was made to use a resolute onyx rx coronary drug eluting stent to treat a severely tortuous and calcified lesion exhibiting 80% stenosis located in the ostium of the left main (lm) coronary artery.The device was inspected with no issues noted.Negative prep was performed without issue.The lesion was pre-dilated.Resistance was not encountered when advancing the device and excessive force was not used.It was reported that the stent deformed and lengthened in vivo and that the stent also dislodged after removal from the patient.The patient was reported to be alive with no injury.

Manufacturer Narrative

Product analysis summary: a dislodged stent was returned for analysis.The stent delivery system was not returned for analysis.Deformation and stretching was evident to the returned stent.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

An attempt was made to deploy the resolute onyx stent at the lesion at 12atm.No difficulties were noted during deployment.It was reported that after stenting, the delivery system was withdrawn and the stent also came out.If information is provided in the future, a supplemental report will be issued.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: 8784190
• MDR Text Key: 150823976
• Report Number: 9612164-2019-02831
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: VM
• 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
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2021
• Device Catalogue Number: RONYX40038X
• Device Lot Number: 0009600313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2019
• 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: 81 YR
• Patient Weight: 68