MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE ONYZ 2.00 X 30; CORONARY DRUG-ELUTING STENT

Model Number RONYX200300K

Device Problems Difficult or Delayed Positioning (1157); Entrapment of Device (1212); Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/28/2022

Event Type  Injury  

Event Description

During a attempted pci of a right coronary artery, difficulty crossing the lesion with the stent occurred.When attempting to remove the stent from the prox rca the stent became dislodged and stuck on the lesion in which we were attempting to treat.After multiple attempt to cross with a balloon and inflate the stent further we were unable.Provider indicated it was likely do to patient anatomy and calcium burden and not device malfunction.No patient harm.Device was not saved by staff post procedure as the stent was retained by the patient in the prox rca.Resolute onyx 2.00 x 30 model # ronyx2003oux lot 00107272222001.Product not available for evaluation.

• Brand Name: RESOLUTE ONYZ 2.00 X 30
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND
• MDR Report Key: 15995207
• MDR Text Key: 305736894
• Report Number: MW5113830
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RONYX200300K
• Device Lot Number: 00107272222001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White