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

Catalog Number UNK-CV-GWY-RONYX

Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/23/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A patient underwent coronary angiography for effort angina, revealing 80% stenosis of the proximal left anterior descending (lad) involving the left main (lm).Pci was performed.A 6f launcher guide catheter was used to engage the left radial artery and a non-mdt guidewire was used.After pre-dilation, a 5.0x12 mm resolute onyx drug eluting stent was deployed at 14atm to the lm to lad and a 3.5x12 mm non-mdt stent deployed to the proximal lad at 14atm.Another 3.0x15 mm non-mdt stent was then deployed to treat the residual distal lad stenosis.High pressure post-dilation at 18atm was performed with a 5.0x12 mm non compliant balloon (non-mdt balloon) in order to optimise the lm stent.Following post dilation of the two lad stents and lm stent then the guidewire was removed.The final angiography showed that the resolute onyx stent had migrated to the more proximal side with its edges deformed, leaving a gap between the lm and lad stents.Further angiography revealed that the onyx was not present in the lm trunk anymore.After a careful fluoroscopy scan, the stent was found in the right deep femoral artery.Another 5.0x15 mm resolute onyx was successfully implanted at 16atm in the lm overlapping the distal lad stent and post-dilation was not performed.A 10 mm loop goose neck snare was then inserted from the contralateral left femoral artery to successfully remove the migrated and deformed stent from the right femoral artery.No further patient injuries or complications were reported post procedure.

Manufacturer Narrative

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: 7266319
• MDR Text Key: 99910796
• Report Number: 9612164-2018-00347
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK-CV-GWY-RONYX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2018
• 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: 52 YR