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

Catalog Number RONYX35022W

Device Problems Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Death (1802); Embolism (1829); Ischemia (1942); Thrombus (2101); Vascular Dissection (3160)

Event Date 11/16/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

During a pci procedure, one resolute onyx otw stent was used to direct stent a mildly tortuous, moderately calcified lesion exhibiting 98% stenosis located in the proximal lad.There was no damage noted to the packaging.There were no issues noted when removing the device from the hoop/tray.Negative prep was performed with no issues.The device did not pass through a previously deployed stent.The lesion was not pre-dilated.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was indicated that there was a waste in the stent at the takeoff of the diagonal branch.That area was post-dilated to expand the stent and the flow to the diagonal branch was compromised.There was a second wire placed in the diagonal branch and a balloon was placed through the stent struts and inflated to reinstate flow.Both wires were removed and the case was completed with issues.It was reported that three days post procedure, the patient presented with chest pain and nausea and was brought to the er and then transferred to ccl.An angiogram revealed that the lad stent was closed along with no distal flow past the proximal stented area.It was thought to be stent thrombosis.The thrombosis was treated by wiring and performing manual thrombectomy using an export catheter to remove the suspected thrombosis along with balloon dilation.The thrombus migrated into the circumflex vessel and left main significantly compromising flow into the lad and circumflex.Ef was 5% and the patient was placed on "emco." the patient was transferred to another facility where patient death occurred.

Manufacturer Narrative

Physician who performed the initial pci stated the onyx stent was not the cause of death.The patient was on dapt at time of the event.The initial pci procedure was completed without any issues except there was a mild waste in the mid stent area and full expansion was not achieved.After the stent thrombosis, there was no flow in the lad starting at the distal stent area.The thrombus migrated into the circumflex vessel upon removal of the export cath with no flow of entire left system causing ischemia.Date of death unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

During a pci procedure one resolute onyx otw stent was used to direct stent a mildly tortuous, moderately calcified lesion exhibiting 98% stenosis located in the proximal lad.There was no damage noted to the packaging.There were no issues noted when removing the device from the hoop/tray.Negative prep was performed with no issues.The device did not pass through a previously deployed stent.The lesion was not pre-dilated.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was indicated that the mid section of the stent at the takeoff of the diagonal branch was not fully expanded.That area was post-dilated to expand the stent and the flow to the diagonal branch was compromised.There was a second wire placed in the diagonal branch and a balloon was placed through the stent struts and inflated to reinstate flow.The initial pci procedure was completed without any issues except there was a mild waist in the mid stent area as full expansion was not achieved.It was reported that three days post procedure the patient presented with chest pain, sob and nausea and was brought to the er and then transferred to ccl.An angiogram revealed that the lad stent was closed along with no distal flow past the proximal stented area.It was thought to be stent thrombosis.The thrombosis was treated by wiring and performing manual thrombectomy using an export catheter to remove the suspected thrombosis along with balloon dilation.The thrombus migrated into the circumflex vessel upon removal of the export cath with no flow of entire left system causing ischemia and left main significantly compromising flow into the lad and circumflex.Ef was 5% and the patient was placed on emco.Upon removal of the export cath with no flow of entire left system causing ischemia.The patient was transferred to another facility where patient death occurred.Physician who performed the initial pci stated the onyx stent was not the cause of death.The patient was on dapt at time of the event.

Manufacturer Narrative

The lesion in the proximal lad was a severe lesion.The 3.5x22mm resolute onyx was inflated once to 15 atm.A decision was made not to go higher than 15 atm because the stent was being over-sized.Preprocedure stenosis was 90% with timi 3 flow.Post procedure stenosis was 0% with timi 3 flow.After crossing the wall of the stent a 2.0 x 15mm sprinter otw balloon was passed over the wire, and was inflated to 8 atm.Preprocedure stenosis was 80-90% with timi 3 flow.Post procedure stenosis was 10% with timi 3 flow.The procedure was successful.Approx 5 days post the initial procedure the patient had elevated troponin.The patient was in cardiogenic shock.The impression was that the patient had acute myocardial infarction caused by stent thrombosis.The very proximal lad was occluded with a large burden of thrombus at the proximal edge of the stented portion.The lesion was predilated with a 2.5x15mm euphora balloon up to 16 atm which restored antegrade flow.There was a question of whether there maybe was a dissection in the prox lad also.The aspiration catheter was placed distally after there was difficulty negotiating the bend.Timi 3 flow looked improved after aspiration but then there was a concern about the terminal left main and origin of the lcx.A large thrombus burden was propagating into the lcx.The patient developed hemodynamic collapse and left main occlusion.An attempt to debulk thrombus from the lad with the aspiration catheter was unsuccessful.A 3.5x18mm resolute onyx stent was implanted in the left main at 12 atm.Angiography showed no improvement with the left main remaining closed.Further aspiration attempt of the stented area into the terminal lad was unsuccessful.Further balloon angioplasty was unsuccessful.Three euphora balloon catheters in total were used during the procedure.The patient was transferred to emory university hospital after ecmo was established.The patient expired on the same day.The physician assessed that medtronic products were not the cause of death, not the stent, not the balloon, not the aspiration catheter.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: two sets of images were provided from the account.The images provided from the procedure on (b)(4) 2018 capture a contrast image showing the lesion in the proximal lad as reported by the account.The tortuous nature of the lesion is visible and patchy regions of contrast along the lesion are suggestive of calcification.A stent is then delivered to the lesion and is deployed but does not fully expand.A dent like appearance in the stent indicates a lesser expanded region.Following placement of the stent there appears to be improved flow in the vessel as shown by the flow of contrast.A balloon device is then inflated within the stent.This could possibly be the post dilation 2.0 x 15mm sprinter otw balloon but this cannot be confirmed.A final angiogram of the initial procedure shows the treated lesion which appears to have improved flow as shown by the path of contrast in the vessel.The second set of images provided from the account capture the procedure on (b)(4) 2018.A contrast image shows an occluded left main and proximal lad.A negative contrast image shows an abrupt discontinued path of contrast where the previously deployed stent in the lad was placed, suggestive of the reported thrombus.A balloon is delivered to the occluded vessel and dilation is performed.Further dilations of the occluded region are performed.A contrast image shows no flow in the lad or lcx suggesting that the lcx was also occluded.A balloon is delivered into the previously deployed stent and expanded.Further dilations performed, and the balloon is delivered to the distal end of the stent and inflated.A final image shows no flow in the lad.There were no images showing the use of the export aspiration catheter.A dissection was not visible in the images.Malapposition could not be verified from the images.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX OTW
• 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: 8173131
• MDR Text Key: 130613404
• Report Number: 9612164-2018-03669
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Catalogue Number: RONYX35022W
• Device Lot Number: 0009013339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2019
• Date Device Manufactured: 02/28/2018
• 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): Death; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 60