MAUDE Adverse Event Report: MEDTRONIC VASCULAR RESOLUTE ONYX; CORONARY DRUG-ELUTING STENT

Model Number RONYX22518UX

Device Problems Retraction Problem (1536); Obstruction of Flow (2423); Failure to Advance (2524); Detachment of Device or Device Component (2907); Positioning Problem (3009)

Patient Problems Death (1802); Ventricular Fibrillation (2130); No Code Available (3191)

Event Date 09/01/2020

Event Type  Death  

Event Description

Pt to cath lab for acute mi/nstemi.Pt had multi-vessel disease, plan was to attempt intervention of r coronary artery, the lesion was a chronic total occlusion and was unable to be crossed.Decision was made to proceed with intervention of l circumflex artery.The lesion was difficult to cross due to angulation.The balloon was able to cross l circumflex lesion.An onyx stent was advanced but would not cross lesion and with pulling back of the stent, it came off the delivery balloon.Attempt was made to retrieve the stent but would not retract and appeared to interrupt flow in lad artery.Pt became unstable and md felt best to proceed with pci to lad.A stent was successfully delivered to that vessel.L circumflex remained occluded, multiple attempts made with different wired but not successful.Surgery consulted.Pt worsened, repeat angiography obtained, showed occlusion of lad stent site so repeat ptca preformed.Pt had reoccurring vfib and acls.Cpr initiated with no response.Pt expired.Fda safety report id# (b)(4).

• Brand Name: RESOLUTE ONYX
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC VASCULAR
• MDR Report Key: 10573282
• MDR Text Key: 208324265
• Report Number: MW5096801
• Device Sequence Number: 1
• Product Code: NIQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Model Number: RONYX22518UX
• Device Lot Number: 0010190154
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 42 YR