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

Catalog Number RONYX30038UX

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/14/2018

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 mildly tortuous and mildly calcified lesion located in the mid right coronary artery, exhibiting 80% stenosis.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.Negative prep was performed with no issues noted.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.The resolute onyx balloon was inflated to 8atm and an attempt was then made to pull out the non-medtronic buddy wire.There were 2 wires placed down the rca.Physician was unable to remove the non-medtronic wire at 8 atm and inflated the stent balloon up to 16 atm for the full deployment of the stent.The non-medtronic wires were unable to be removed after the second inflation.Physician then tried to remove the entire system and noted that the balloon shaft had been snapped in half distal to the balloon.The device was not kinked and re-straightened during use.The portion of the device does not remain in patient.The remaining part to the stent catheter was removed using a snare.Patient status post-procedure is alive with no injury.

Manufacturer Narrative

Additional information: the stent was not completed deployed, and the stent came off the catheter, and ended up migrating down the rca.The stent was retrieved from the rca by a snare technique and was completely removed out of the rca.It is unknown what happened first, the shaft breaking or the stent coming off.Evaluation summary: the stent was not present on the balloon and did not return for analysis.The balloon folds were expanded.Crimp impressions were visible on the exposed balloon surface.The inner lumen could not be verified with a 0.015 inch mandrel most likely due to hardened blood in the guidewire lumen.The delivery system returned with a detachment on the transitional tubing 35.3cm proximal to the distal tip.The transitional tubing material was oval and jagged on both sides of the detachment site.Kinks were not evident on the transitional tubing proximal or distal to the detachment site.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: 7812213
• MDR Text Key: 118086610
• Report Number: 9612164-2018-02158
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169557048
• UDI-Public: 00643169557048
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2020
• Device Catalogue Number: RONYX30038UX
• Device Lot Number: 0009016962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2018
• 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: 72 YR