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

Model Number RONYX30022X

Device Problems Inflation Problem (1310); Leak/Splash (1354); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/06/2018

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 non-tortuous, moderately calcified lesion exhibiting 100% chronic total occlusion located in the distal rca.The device was inspected with no issues.Negative prep was performed with no issue.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.It is reported that during deployment of the stent the balloon could not be fully inflated with only 1 atm of pressure being achieved.It is reported that a balloon leak occurred.An attempt was made to remove the stent from the patient however the stent dislodged inside the patient.The dislodged stent remains inside the patient.The procedure was completed by deploying another medtronic stent inside the dislodged stent.The patient is reported to be alive with no injury.

Manufacturer Narrative

The procedure was completed by deploying another resolute onyx stent of the same size inside the dislodged stent.Only one stent device damaged during the procedure.Device lot initially reported as 0009157420 subsequently reported as 0008759640.Correction: product analysis summary: the balloon returned with blood visible in the balloon and inflation lumen.Crimp impressions were not visible on the exposed balloon surface.The balloon folds were expanded.The inner lumen could not be verified with a 0.015 inch mandrel most likely due to hardened blood in the guidewire lumen.The balloon failed negative prep.On pressurisation of the delivery system, liquid was observed exiting the balloon working length.The balloon failed to maintain pressure.Upon visual inspection of the device, there was a longitudinal tear on the balloon material from the mid-section of the balloon working length to the proximal cone.The balloon material was jagged and uneven at the tear site.Lead in scratches were not evident proximal or distal to the tear site.No other damage evident to the remainder of the delivery system.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Addition information: patient gender initially reported as female and subsequently reported as male.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: 8119165
• MDR Text Key: 128863401
• Report Number: 9612164-2018-03428
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 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: 01/01/2020
• Device Model Number: RONYX30022X
• Device Catalogue Number: RONYX30022X
• Device Lot Number: 0008759640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2018
• Initial Date FDA Received: 11/30/2018
• Supplement Dates Manufacturer Received: 01/23/2019; 03/05/2019
• Supplement Dates FDA Received: 02/19/2019; 03/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2018
• 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: 56 YR
• Patient Weight: 76