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

Model Number RONYX30015W

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 01/15/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A resolute onyx coronary drug eluting stent was attempted to be used to treat a moderately tortuous, severely calcified lesion in the proximal rca.The device was inspected with no issues noted.Negative prep was performed with no issues.It was reported that stent dislodgement occurred during removal following failed delivery.The patient was then sent to surgery to remove the dislodged stent.

Manufacturer Narrative

A review of the case notes was conducted by the account.There was no mention in the notes of the dislodged stent being in pieces.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: eval code-conclusion code added correction: adverse event and product problem selected intervention required ticked device code c62917 added if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the patient was brought back to the cath lab one day later to receive additional diagnostic imaging to locate the stent.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

It was reported that a piece of the stent broke off upon dislodging from the balloon.Carotid images were subsequently taken.The decision was made to take the patient to or for carotid exploration.The stent was unable to be located in the carotid.It was later determined that the piece of stent had migrated to the patients kidney.The patient was admitted for a laparoscopic procedure, however, the procedure was unsuccessful in retrieving the dislodged piece of stent.The stent piece remains in the patients kidney.The patient has since been discharged and is reportedly not experiencing any problems.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX OTW
• 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: 9630995
• MDR Text Key: 176557533
• Report Number: 9612164-2020-00409
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169602502
• UDI-Public: 00643169602502
• 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: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2020
• Device Model Number: RONYX30015W
• Device Catalogue Number: RONYX30015W
• Device Lot Number: 0009186613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2020
• Date Device Manufactured: 06/13/2018
• 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: 64 YR
• Patient Weight: 114