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

Catalog Number RONYX27515X

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Atrial Fibrillation (1729); Cardiomyopathy (1764); Chest Pain (1776); Pneumonia (2011); Thrombus (2101); Ventricular Fibrillation (2130); Abdominal Distention (2601)

Event Date 06/11/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient presented with acute central chest pain, with severe intensity and anterolateral st elevation.Pci was performed to treat a 100% mid occlusion lesion in the lad.There was small diagonal 2 branch at the point of occlusion in the mid lad.The lesion was pre-dilated four times (10 atm, 12 atm, 12 atm, 8 atm) using a 2.5x15 mm euphora rx balloon.Two resolute onyx rx coronary drug eluting stents (2.75x18 mm and 2.5x15 mm) were overlapped and deployed in the lad.The 2.75x18 mm device was deployed at 15 atm.The stents were post-dilated to high pressure using a 3.0x12 mm balloon.A very good angiographic result was achieved after intra coronary verapamil boluses was performed to treat slow/ no flow in the distal lad.Patient was prescribed dapt for one year and nuseal aspirin for life along with betablocker and statin.After the patient had been discharged from the ccu it was reported that stent thrombosis and distal malapposition occurred in the lad.Recanalisation was performed in the cath lab.The patient suffered multiple further ventricular fibrillation arrests in the following days which required cpr and defibrillation.A temporary pacing wire was inserted.The patient developed hospital acquired pneumonia while they were in the icu and this was treated with antibiotics.Approximately seven days after admission the patient had abdominal distention due to ischaemic colitis and a further ventricular fibrillation occurred.An externalised pacemaker was inserted and later extubated and the patient was moved to the ccu.An icd (implantable cardioverter defibrillator) was inserted two weeks prior to discharge.Patient also developed myopathy and atrial fibrillation.The patient was discharged from the hospital on a later date.

Manufacturer Narrative

Correction: event date was (b)(6) second resolute onyx was ronyx27515x additional information: patient presented with acute central chest pain, with severe intensity and anterolateral st elevation.Pci was performed to treat a 100% mid occlusion lesion in the lad.Access was through the right radial artery 6fr.There was small diagonal 2 branch at the point of occlusion in the mid lad.There was diffuse distal disease in the distal lad.The lesion was pre-dilated four times (10 atm, 12 atm, 12 atm, 8 atm) using a 2.5x15 mm euphora rx balloon.Two resolute onyx rx coronary drug eluting stents (2.75x18 mm and 2.75x15 mm) were overlapped and deployed in the lad.The 2.75x18 mm device was deployed at 15 atm.The 2.75x15mm resolute onyx was deployed at 12atm at 47 seconds, and 14 atm at 7 seconds.The stents were post-dilated to high pressure using a 3.0x12 mm nc balloon.A very good angiographic result was achieved after intra-coronary verapamil boluses was performed to treat some slow/no flow in the distal lad.Patient was prescribed dapt for one year and nuseal aspirin for life along with betablocker and statin.Patient presented one day after seven days post discharge from the ccu with chest pain followed by collapse at home.The patient received chest compressions and 2 shocks by paramedics due to ventricular fibrillation.The patient was brought to the cath lab and it was reported that stent thrombosis and distal malposition had occurred in the lad.Pci/recanalisation was performed in the cath lab.A resolute onyx stent was used and a non-medtronic balloon.The patient was intubated and ventilated in icu with vasopressor support following recanalisation in cath lab.The patient suffered multiple further ventricular fibrillation arrests in the following days which required cpr and defibrillation.A temporary pacing wire was inserted.The patient developed hospital acquired pneumonia and this was treated with antibiotics.Approximately seven days after admission the patient had abdominal distention due to ischaemic colitis and a further ventricular fibrillation occurred.Subtotal colectomy was performed for the ischaemic bowel.Gram negative septicaemia was treated with antibiotics.An externalised pacemaker was inserted and later extubated and the patient was moved to the ccu.Patient also developed icu myopathy, atrial fibrillation, anuric kidney injury of unknown cause and a urinary tract infection.An icd (implantable cardioverter defibrillator) was inserted two weeks prior to discharge.The patient was discharged from the hospital on a later date.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Event date.The event occurred approx one week post implant ((b)(6) 2018) of the two resolute onyx stents.(b)(4).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: 8027618
• MDR Text Key: 125761108
• Report Number: 9612164-2018-03017
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2020
• Device Catalogue Number: RONYX27515X
• Device Lot Number: 0009029951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2018
• Date Device Manufactured: 03/12/2018
• 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: 69 YR
• Patient Weight: 77