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

Catalog Number RONYX40022X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aneurysm (1708); Cardiac Arrest (1762); Cardiopulmonary Arrest (1765); Death (1802); Hematoma (1884); Hemoptysis (1887); Hemorrhage/Bleeding (1888); Rupture (2208); Blood Loss (2597); Pseudoaneurysm (2605); Respiratory Arrest (4461)

Event Date 07/27/2020

Event Type  Death  

Manufacturer Narrative

Journal article: coronary artery aneurysm after drug-eluting stent implantation causing coronary-bronchial fistula authors: ankush gupta, rajat datta, sanya chhikara, peeyush k.Dhagat, rajesh vijayvergiya journal: jacc: case reports year: 2020 reference: https://doi.Org/10.1016/j.Jaccas.2020.07.Date of publication procedural and still images in the article provided the basis of analysis.The first image shows the coronary angiography at initial presentation in which the diseased lm, lad and lcx arteries can be seen.The second image shows the coronary angiography after the lm bifurcation angioplasty.The third image shows the ct angiography in which the aneurysm and the intramural hematoma can be seen adjacent to the lcx stent.The image also shows presence of air within the aneurysm and a left atrial¿left ventricular lateral wall intramural hematoma, suggestive of ruptured left circumflex aneurysm and its communication with the left main bronchus and left lung.The fourth image depicts the coronary angiography after the lcx aneurysm rupture in which a leaking left lcx aneurysm can be seen.The final image is of an autopsy specimen showing a ruptured lcx pseudoaneurysm with an adjacent left atrial (la)¿left ventricular (lv) lateral wall intramural hematoma.If information is provided in the future, a supplemental report will be issued.

Event Description

A case report was submitted.During an index procedure pci was performed in the lad.A 6f ebu guide catheter was used.Lm artery dissection occurred with compromised flow to the lad and lcx.Bailout bifurcation pci was performed and five resolute onyx coronary drug eluting stents deployed at 12 atm.A 4 x 22 mm stent was implanted in the lm - proximal lad, a 3 x 22 mm in the proximal - mid lad, a 2.75 x 33 mm in the mid lad, a 2.75 x 18 mm in the osteoproximal lcx and a 2.5x18 mm in the lcx - om major, overlapping the previous stent.Final kissing balloon inflation was carried out in the lm, lad, lcx using nc balloons.Patient was discharged on dapt.Eight weeks later the patient presented with 3-day history of cough, hemoptysis, pain in the left lower chest, and generalized weakness.Patient also had differential diagnosis including lung parenchymal infection (bacterial or tubercular), a noninfective lung parenchymal lesion such as a tumor, pulmonary embolism, and coronary artery aneurysm (caa).Chest ct revealed a proximal lcx aneurysm compressing the atrioventricular (av) junction, a left atrial (la) and left ventricular (lv) lateral wall intramural hematoma, and adjacent lung parenchymal consolidation.Patient started on iv antibiotics.Coronary angiography was planned however the patient had episode of massive hemoptysis and cardiopulmonary arrest and was revived after cardiopulmonary resuscitation.Repeat ct showed air in the ruptured lcx aneurysm and a la-lv lateral wall intramural hematoma, p neumopericardium, blood in left main bronchus and air space opacities.An emergency coronary angiography showed a ruptured fusiform aneurysm in the proximal lcx artery that was bleeding into the pleuropulmonary space.The lad and lcx were wired but high flow from the ruptured site caused the lcx wire to go into the pleuropulmonary space and could not be negotiated to the distal lcx.A non-medtronic stent was placed in the lm to the lad across lcx, controlling the lcx leak.Thereafter, the patient developed generalized tonic-clonic seizures secondary to hypoxic-ischemic encephalopathy, bleeding gastric ulcers, ventilator-associated pneumonia, and right lung collapse, and he was treated with intravenous antiepileptic agents, endoscopic hemoclips, upgraded antibiotics, and bronchoscopy.The patient remained critically ill with ongoing hypoxicischemic encephalopathy, ventilator-associated pneumonia, and sepsis.Five days post aneurysm rupture the patient had a sudden cardiac arrest and dies of their illness.Autopsy revealed a pseudoaneurysm around the proximal lcx stent with an intramural hematoma in the la and lv lateral wall compressing the left av junction.The ruptured aneurysm was also seen to be communicating with left main bronchus and left lung parenchyma through a fistula between the wall of the left atrium and the lower lobe of the left lung.The lcx artery showed overlapping in situ metallic stents in its lumen with aneurysmal dilation.

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: 10801257
• MDR Text Key: 215091145
• Report Number: 9612164-2020-04301
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RONYX40022X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2020
• 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; Other; Required Intervention
• Patient Age: 42 YR