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 2020-03-14 for TRIEVER20 21-101 manufactured by Inari Medical, Inc..
[183473793]
Inari's chief medical officer conferred with the attending physician to review the case and offer support. The conclusion was that the patient presented with acute on chronic pulmonary hypertension and progressive right heart failure. The pericardial effusion was likely a complication related to the procedure, but the patient did not die of cardiac tamponade, as it was drained early and effectively and did not recur; the cause of death was believed to be right-sided heart failure. Unfortunately, the patient was not stable enough to be transferred to a facility with mechanical circulatory support. The device was discarded by the user facility and is not available for evaluation. There was no allegation of a device malfunction. The device history records were reviewed for this manufacturing lot and there were no discrepancies or unusual findings that relate to the reported event. Pericardial effusion is listed in the device labeling as a potential complication / adverse event. Manufacturer reference #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[183473794]
A (b)(6)-year-old male patient with a history of high blood pressure and diabetes was diagnosed with a pulmonary embolism (pe) with clot identified via computed tomography (ct) angiography in the basal trunk of the left interlobar artery, as well as the right pulmonary artery (pa) with clot extending into the truncus anterior. At baseline, the patient's vital signs were: heart rate 110 bpm, systolic blood pressure approx. 170 mmhg, right ventricle/left ventricle (rv/lv) ratio 1. 6, hemoglobin count 15. 2 gm/dl, blood oxygen saturation 94% on 2 l oxygen. On (b)(6) 2020, the inari medical triever20 was used to treat the pe. Prior to pa access, the right atrial pressure measured 25/21/18 mmhg while the right ventricle measured 81/4/27 mmhg. Access into the pa was gained through a balloon tip catheter within 60 seconds, after which time the pa pressure measured 93/30/51 mmhg. After exchanging the terumo glidewire with an amplatz super stiff guidewire the in right lower lobe, a kink was observed 7 cm from the tip. After consultation, the team realized a 7 cm floppy tip was inadvertently used instead of the recommended 1 cm, so this was exchanged for a 1 cm amplatz super stiff guidewire. The triever20 was placed over the guidewire and advanced without difficulty into the lower right interlobar branch and there were no signs of distress. Three successive aspirations using inari's 60 cc syringe produced no clot and what appeared to be laminated blood. Two additional aspirations yielded no clot and laminated blood. Imaging after 20 cc of contrast and 30 cc of saline identified poor perfusion in the lower right lobe, corresponding to the original ct angiography. With the guidewire left in place, the inari triever 20 dilator was replaced and the triever20 was repositioned in the right side. Eleven aspirations yielded only two small clots and 660 cc blood. Pulmonary angiography of the right lower lobe showed improved perfusion. Remeasurement of the right pa pressure showed significant improvement at 43/27/35 mmhg. The triever20 was removed from the patient and the physician decided to move the to the left pa using the amplatz ss 1 cm guidewire. The triever20 was advanced into the left pa without issue. The first aspiration using a 60 cc syringe yielded no clot and 40 cc of blood. A 2nd aspiration attempt yielded no clot along with 30 cc of blood removed. In a 3rd aspiration attempt, the physician retracted the triever20 without removing any clot was removed. The dilator was replaced and the triever20 was repositioned to its original position. Again, no clot was removed after 2 syringe aspirations. At this time the company representative left the catheter lab to procure an inari triever16 catheter. Upon returning, all devices had been removed except the amplatz jr4 catheter and the patient reported chest pain. Pulmonary arteriograms showed clot in the left pa, but no extravasation. The patient moved and complained of worsening chest pain and lower back pain. Vasopressors and fluids were administered and the cardiothoracic surgeon and heart team arrived. The patient was intubated in order to mitigate movement; there was no coughing or signs of hemoptysis. The patient was responding to the additional fluids and vasopressors, but the right ventricle did not appear to be circulating blood properly; chest echography revealed pericardial effusion. Cardiopulmonary resuscitation was administered intermittently as needed and the patient would respond, but deteriorate after 5 minutes. The attending physician performed a pericardiocentesis and removed approximately 250 cc fluid; at this time the hemoglobin was 10 gm/dl. Since 840 cc of blood was removed during the thrombectomy procedure, 2 units of blood were given. The option of transferring the patient to another facility with access to ecmo was ruled out due the patient's instability. Hemoglobin was tested again and was 9 gm/dl, indicating the patient was likely bleeding from an undetermined location. Cardiopulmonary resuscitation was repeated over the next couple hours. The patient's hemoglobin later measured 11 gm/dl and no fluid was observed on chest echography. Cpr efforts continued into the early morning of (b)(6) 2020, at which time cpr was discontinued and the patient expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011525976-2020-00004 |
| MDR Report Key | 9832968 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-14 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2020-01-29 |
| Date Added to Maude | 2020-03-14 |
| 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 | 2020-03-14 |
| Model Number | 21-101 |
| Lot Number | 20010004 |
| 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. Death; 2. Life Threatening; 3. Required No Informationntervention | 2020-03-14 |