MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-18 for TRIEVER20 21-101 manufactured by Inari Medical, Inc..
[186832018]
The device was discarded by the user facility and is not available for evaluation. The device history records were reviewed for this manufacturing lot and there were no discrepancies or unusual findings that relate to the reported event. The case was reviewed by inari's chief medical officer who concluded that nothing wrong occurred during the inari procedure. The patient's preexisting cteph and pts are high-risk factors that can predispose technical challenges / worse clinical outcomes and the chronic lung scarring / venous system scarring decreased the likelihood of a return to normal physiology. Additionally, the acute-on-chronic right heart failure is extremely dangerous, resulting in poor right heart reserve. If the triever catheter is over-advanced, it has the potential to move the clot distally. The danger is that a partially occlusive clot acutely affects previously unaffecting lung segments by pushing clot into smaller branches, making it occlusive. Because of the poor right heart reserve, even this small change can cause dramatic decompensation. Distal embolization and hypotension are listed in the device labeling as potential complications / adverse events. Manufacturer reference #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186832019]
A (b)(6)-year-old female patient with post thrombotic syndrome (pts) and chronic thromboembolic pulmonary hypertension (cteph) with a history of pulmonary embolism (pe) and deep vein thrombosis developed a massive pe after non-compliance with the prescribed anticoagulation medication. The patient's vital signs were: heart rate 88-90 bpm, blood pressure 120/80 mmhg, and blood oxygenation saturation 97-98%. The patient was admitted to the icu on (b)(6) 2020 and on (b)(6) 2020, inari medical's triever20 was used to treat the pe. After access was gained via a right transfemoral approach, an angled pigtail catheter was placed in the pulmonary artery. Hemodynamic measurements included left pulmonary artery (pa) pressure of 65/16/38 (systolic, diastolic, mean) mmhg, main pa measured 63/6/32 mmhg, and right pa 57/14/35 mmhg. A cook medical bentson 0. 035" guidewire was placed distally in the lower right lobe, targeting thrombus in the right pa. The access site was upsized to a 22 fr gore dryseal to accommodate the triever20, which was then advanced to the right lobe beyond the targeted clot (saddle wrapped around the truncus anterior). The pulmonary angiogram revealed the clot moved distally or up the truncus anterior. There was uncertainty whether the triever20 dislodged the clot since hemodynamics remained unchanged. Vacuum aspiration with inari's large bore syringe yielded thick, fibrotic and macerated clot. After aspiration, systolic blood pressure decreased to the mid-50s mmhg and the patient vomited. Anesthesia was reversed and within 10 minutes blood pressure normalized to 120/80 mmhg. Repeat pulmonary angiography showed some remaining clot distally in the lower lobe. The decision was made to reposition the triever20 to the left pa where two aspirations yielded two large pieces of acute-on-chronic clot. Repeat pulmonary angiography confirmed perfusion in the lower left lobe. The main pa pressure was 79/17/40 mmhg, so the physician felt comfortable attempting to extract the clot remaining in the truncus anterior. There was some difficulty positioning the bentson guidewire in the lower lobe, so the physician positioned the triever20 into the main pa, then advanced the guidewire to the truncus anterior. Immediately, patient's systolic blood pressure decreased to the low 40s and a code was initiated. The patient coughed, but there was no hemoptysis. Subsequent angiography confirmed the absence of a perforation in the truncus anterior area where the guidewire was placed; final main pa pressure measured 62/1/27 mmhg. The patient was placed on extracorporeal membrane oxygenation (ecmo) and was responsive to commands. One of the physicians commented that the patient has right ventricle failure which should have warranted earlier intervention. As of (b)(6) 2020, patient was reported as stable and doing fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011525976-2020-00005 |
| MDR Report Key | 9849549 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2019-11-07 |
| Date Added to Maude | 2020-03-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EBEN GORDON |
| Manufacturer Street | 9 PARKER SUITE 100 |
| Manufacturer City | IRVINE, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 6008433114 |
| Manufacturer G1 | INARI MEDICAL, INC. |
| Manufacturer Street | 9 PARKER SUITE 100 |
| Manufacturer City | IRVINE, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIEVER20 |
| Generic Name | EMBOLECTOMY CATHETER |
| Product Code | QEW |
| Date Received | 2020-03-18 |
| Model Number | 21-101 |
| Lot Number | 19070018 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INARI MEDICAL, INC. |
| Manufacturer Address | 9 PARKER SUITE 100 IRVINE, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2020-03-18 |