MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA NV MICROCATHETER; CATHETER, CONTINUOUS FLUSH

Device Problems Break (1069); Burst Container or Vessel (1074); Compatibility Problem (2960)

Patient Problems Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.The reported adverse events are inherent risk of endovascular procedure and are documented in our device¿s instruction for use (ifu).Attempts were made to obtain additional event details.Linked with mdr: 2029214-2020-00635 and 2029214-2020-00636.If information is provided in the future, a supplemental report will be issued.

Event Description

D.F.Vollherbst, c.Herweh, s.Schönenberger, f.Seker, s.Nagel, p.A.Ringleb, m.Bendszus, and m.A.Möhlenbruch.¿the influence of angioarchitectural features on the success of endovascular embolization of cranial dural arteriovenous fistulas with onyx¿ ajnr am j neuroradiol.2019 dec;40(12):2130-2136.Doi: 10.3174/ajnr.A6326.Epub 2019 nov 21.104 patients with 110 davfs who were treated with endovascular embolization using onyx in 132 treatment procedures were included in this study.The mean age was 57.4 6 13.0 years, and the male/female ratio was 2:5.Most patients (93.3%) were symptomatic.The overall complication rate was 8.3%, of which 6 (4.5%) were asymptomatic, 3 (2.3%) were transient, and 2 (1.5%) were permanent.The asymptomatic and transient complications included small intracranial hemorrhages, most likely caused by vessel perforation, material-related complications such as catheter occlusion, rupture, or retention, as well as small venous infarctions.Both of the permanent complications were fatal large intracerebral hemorrhages of cognard type iv/borden type iii davfs.The first patient initially presented with severe sinus thrombosis, venous congestion, and obstructive hydrocephalus.In this patient, only subtotal embolization of the davf could be achieved due to the small caliber and the tortuosity of the feeding arteries.Immediately after extubation, the patient developed a large intracerebral hemorrhage, most likely caused by venous congestion.In the second patient, complete angiographic occlusion was achieved in 2 treatment procedures.This patient was asymptomatic after extubation until he experienced increasing headache 3 hours after the second treatment procedure.The subsequent ct scan showed a large intracerebral hemorrhage causing the patient¿s death on the day of the second treatment procedure.For this patient, no specific cause of the intracerebral hemorrhage could be found.The initial complete angiographic occlusion rate was 78.2%.There was spontaneous occlusion after subtotal initial occlusion in 14 patients (12.7%) after a mean time of 6.6 months, resulting in a complete angiographic occlusion rate of 90.9%.After a mean follow-up of 23.6months, 66.4% of patients were free of symptoms, 29.1% showed symptom relief, 2.7% showed stable symptoms, and 1.8% showed worsening of symptoms after treatment.Treatment success was achieved in 90 patients (81.8%).Recurrence after complete angiographic occlusion (diagnosed with dsa) was observed in 4 cases (3.6%): three davfs were successfully re-treated with endovascular onyx embolization and 1 davf was successfully treated by neurosurgical ligation of the fistula.Complications : asymptomatic complications 6 (4.5%) transient symptomatic complications 3 (2.3%) permanent complications 2 (1.5%) symptom relief after treatment 32 (29.1%) stable symptoms after treatment 3 (2.7%) worsening of symptoms after treatment 2 (1.8%) treatment success 90 (81.8%).

• Brand Name: NV MICROCATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10217494
• MDR Text Key: 198109329
• Report Number: 2029214-2020-00637
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2020
• 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): Other