MAUDE Adverse Event Report: PERFUSION SYSTEMS EOPA ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number 77418

Device Problem Malposition of Device (2616)

Patient Problems Stroke/CVA (1770); Vascular Dissection (3160); Thrombosis/Thrombus (4440)

Event Date 11/19/2020

Event Type  Injury  

Manufacturer Narrative

Medtronic investigation: medtronic cannot confirm or deny the complaint of the type b aortic dissection, cerebral infarct and thrombotic cast during use as no product has been returned to date.A root cause of this occurrence cannot be determined without returned product, however, there is a possibility the adverse effects were caused during atraumatic placement of the cannula.Based on the instructions for use (ifu) this product is not intended to be used for ecmo (intended to be used less than 6 hours), and is not intended to be placed in the descending aorta, as was the placement in the literature article.The literature article does not identify any device malfunctions associated with the cannula.The device history record could not be reviewed as no lot number was provided.Complaints received for similar model numbers were reviewed and showed no trends warranting escalation related to this occurrence.The investigation was completed with the information that was provided, if additional information is received, the complaint file will be reopened if deemed necessary.If the product is returned, this pe will be reopened and the analysis and investigation will be updated.Medtronic will continue to monitor for future occurrences and trends.Citation: fukunaga et al.Descending aortic thrombosis and acute type b dissection during central extracorporeal membrane oxygenation: a word of caution.Jtcvs techniques 2021;6:85-7.Doi: org/10.1016/j.Xjtc.2020.11.006 epub 2020 nov 19.Date of publish used for date of event.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether this event has been previously reported.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a case of simultaneous aortic thrombosis and acute type b aortic dissection (ad) caused by an arterial cannula placed in the descending aorta.All data were collected from a single center.A (b)(6) woman with a previous mitral commissurotomy via thoracotomy was admitted to another facility due to heart failure, sev ere mixed rheumatic mitral disease, and left ventricular ejection function of 45% with normal right ventricular function.Coronary angiography showed normal coronary arteries.The patient underwent redo mechanical mitral valve replacement and maze procedure for atrial fibrillation.At surgery, the right ventricle was lacerated on entry.The patient was sent to the intensive care unit with high-dose inotropic and vasopressor supports.The patient remained hemodynamically unstable and the next day was taken back to the operating room to relieve tamponade, and an intra-aortic balloon pump was inserted.Hemodynamic instability persisted; therefore, central veno-arterial extra corporeal membrane oxygenation (va-ecmo) was initiated with cannulas in the right atrium, ascending aorta, and right superiorpulmonary vein for venting.The patient¿s coronary arteries were reassessed and were widely patent.Transesophageal echocardiography showed no evidence of ascending or descending ad and thrombosis.The patient was transferred to toronto general hospital for ongoing care.Chest radiograph on arrival showed the tip of the aortic cannula in the descending aorta.The patient¿s heart improved and 6 days later she was successfully decannulated.The aortic eopa cannula had been placed in the distal ascending aorta and placed deeply to the transition zone so that the tip was indeed in the descending aorta.The cannulation technique and methods of confirmation of positioning performed at another hospital were not described in the article.While the patient was on ecmo, activated partial thromboplastin time was maintained between 40 and 60 seconds.Postoperatively, her creatinine rose from 92 to 280 mmol/dl.Transesophageal echocardiography revealed a thrombotic cast where the aortic cannula was along with an intimal flap suggestive of type b ad.Abdominal ultrasound confirmed that the intimal flap was confined to the thorax.Computed tomography was not used due to the elevated creatinine and further damage related to contrast.Computed tomography of the brain revealed a cerebral infarct in the posterior limb of the right middle cerebral artery without evidence of hemorrhage.Anticoagulation was initiated, and medical management for the type b ad was commenced.The patient was discharged from the hospital with normal cardiac, renal, and neurologic recovery.Based on the available information, the type b aortic dissection, cerebral infarct and thrombotic cast may have been attributed to the medtronic product no device malfunctions occurred.No additional adverse patient effects or product performance issues were reported.

• Brand Name: EOPA ARTERIAL CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12031377
• MDR Text Key: 257128134
• Report Number: 2184009-2021-00050
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 77418
• Device Catalogue Number: 77418
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/21/2021
• Was Device Evaluated by Manufacturer?: No
• 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: 49 YR