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

Catalog Number RONYX20022X

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/30/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a moderately tortuous and calcified lesion located in the distal rca.The device was inspected with no issues.The lesion was not pre-dilated.The device did not pass through a previously deployed stent.It was reported that stent dislodgement occurred during delivery to/at the lesion.The dislodged stent was removed using a small sc balloon.

Manufacturer Narrative

There were no difficulties noted when removing the protective sheath.The inflation device remained on neutral pressure during delivery.The device did pass through a previously deployed stent.Resistance was not encountered when advancing the device and excessive force was not used.Product analysis summary: the stent was not present on the balloon.The balloon folds remained intact.Crimp impressions were visible on the exposed balloon surface.Deformation was evident to the dislodged stent.The inner lumen could not be verified with a 0.015 inch mandrel most likely due to hardened blood in the guidewire lumen.There was no other damage evident to the remainder of the device.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: 8301791
• MDR Text Key: 134891178
• Report Number: 9612164-2019-00407
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2020
• Device Catalogue Number: RONYX20022X
• Device Lot Number: 0008936818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/04/2019
• Supplement Dates Manufacturer Received: 02/11/2019
• Supplement Dates FDA Received: 03/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2018
• 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