MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE FR; CATHETER, THROMBUS RETRIEVER

Model Number UNK-NV-SFR

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

Patient Problem Insufficient Information (4580)

Event Date 03/01/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

Thomas r.Meinel, joachim u.Kniepert, david j.Seiffge, jan gralla, simon jung, elias auer, sebastién frey, martina goeldlin, pasquale mordasini, pascal j.Mosimann, raul g.Nogueira, diogo c.Haussen, gabriel m.Rodrigues, timo uphaus, vincent l¿allinec, dagmar krajícková, angelika alonso, vincent costalat, steven d.Hajdu, marta olivé-gadea, christian maegerlein, laurent pierot, joanna schaafsma, kentaro suzuki, marcel arnold, mirjam r.Heldner, urs fischer, johannes kaesmacher.Endovascular stroke treatment and risk of intracranial hemorrhage in anticoagulated patients.Stroke 51 (2020).Doi: 10.1161/strokeaha.119.026606 background and purpose¿we aimed to determine the safety and mortality after mechanical thrombectomy in patients taking vitamin k antagonists (vkas) or direct oral anticoagulants (doacs).Methods¿in a multicenter observational cohort study, we used multiple logistic regression analysis to evaluate associations of symptomatic intracranial hemorrhage (sich) with vka or doac prescription before thrombectomy as compared with no anticoagulation.The primary outcomes were the rate of sich and all-cause mortality at 90 days, incorporating sensitivity analysis regarding confirmed therapeutic anticoagulation.Additionally, we performed a systematic review and meta-analysis of literature on this topic.Results¿altogether, 1932 patients were included (vka, n=222; doac, n=98; no anticoagulation, n=1612); median age, 74 years (interquartile range, 62¿82); 49.6% women.Vka prescription was associated with increased odds for sich and mortality (adjusted odds ratio [aor], 2.55 [95% ci, 1.35¿4.84] and 1.64 [95% ci, 1.09¿2.47]) as compared with the control group, whereas no association with doac intake was observed (aor, 0.98 [95% ci, 0.29¿3.35] and 1.35 [95% ci, 0.72¿2.53]).Sensitivity analyses considering only patients within the confirmed therapeutic anticoagulation range did not alter the findings.A study-level meta-analysis incorporating data from 7462 patients (855 vkas, 318 doacs, and 6289 controls) from 15 observational cohorts corroborated these observations, yielding an increased rate of sich in vka patients (aor, 1.62 [95% ci, 1.22¿2.17]) but not in doac patients (aor, 1.03 [95% ci, 0.60¿1.80]).Conclusions¿patients taking vka have an increased risk of sich and mortality after mechanical thrombectomy.The lower risk of sich associated with doac may also be noticeable in the acute setting.Improved selection might be advisable in vka-treated patients.- 21 patients in the doac group, 64 patients in the vka group, and 347 patients with no oral anticoagulation had died at 3 months.

• Brand Name: SOLITAIRE FR
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 11366296
• MDR Text Key: 233091040
• Report Number: 2029214-2021-00196
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-SFR
• Device Catalogue Number: UNK-NV-SFR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2021
• 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