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

Catalog Number RONYX30015UX

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Physical Resistance/Sticking (4012)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 06/15/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A resolute onyx drug eluting stent was attempted to be used to treat a tight lesion in a saphenous vein graft.There was no damage noted to the device packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues.Negative prep was not performed.Difficult catheter engagement and force was needed to reach the lesion.Several delivery attempts were made with forward pressure.Resistance was encountered when advancing the device.It is reported that the stent dislodged during delivery to the lesion.The physician attempted to expand the stent with a balloon but the stent travelled to the periphery.Fluoroscopy confirmed that the dislodged stent traveled to the hypogastric artery.The stent remains in the patient.The initial intended intervention was still performed successfully using a new stent.No patient injury is reported.

Manufacturer Narrative

Additional information: no difficulty noted removing the sheath.The inflation device remained on neutral.The device did not pass through a previously deployed stent.The lesion was pre dilated.Force was used as there was calcium , but not excessive force.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.

Manufacturer Narrative

The patient underwent a cardiac cath with des placement to the rca and pda.The dislodged stent travelled to the small hypogastric artery off the right iliac.Due to its location, no further intervention was pursued.The patient tolerated the procedure.The patient was discharged.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: 7669432
• MDR Text Key: 113403323
• Report Number: 9612164-2018-01665
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556980
• UDI-Public: 00643169556980
• 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: 01/16/2019

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: 02/15/2020
• Device Catalogue Number: RONYX30015UX
• Device Lot Number: 0008997536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2019
• 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
• Patient Age: 80 YR