MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR NV MICROCATHETER; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-MICROCATH

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

Patient Problems Intracranial Hemorrhage (1891); Perforation of Vessels (2135); Vascular Dissection (3160)

Event Date 06/01/2014

Event Type  Injury  

Event Description

Weinberg jh, sweid a, sajja k, abbas r, asada a, kosak o, mackenzie l, choe h, gooch mr, herial n, tjoumakaris s, zarzour h, rosenwasser rh, jabbour p.Posterior circulation tandem occlusions: classification and techniques.Clinical neurology and neurosurgery (2020), 198.Doi: https://doi.Org/10.1016/j.Clineuro.2020.106154.  medtronic literature review found a report of postprocedural symptomatic ich, periprocedural ich/sah, periprocedural vessel dissection, periprocedural vessel perforation, and mortality in association with mechanical thrombectomy using solitaire fr, react catheter, and onyx.  the purpose of this article was to characterize posterior circulation tandem occlusions as there is little information in current literature.The authors reviewed 17 cases of patients treated for mechanical thrombectomy between june 2014 and november 2019.Of the 17 patients, the average age was 56 years, 6 were female and 11 were male.The mean number of device passes was 2.24 ± 2.02, recanalization failure occurred in 4 (23.5%) patients, the mean time from stroke onset to puncture was 6.9 ± 2.4 h, and the mean time from puncture to recanalization was 59.3 ± 26.6 min.Tici score>2b was achieved in 13 (76.5%) patients.An improvement in nihss>3 at discharge occurred in 10 (58.8%) patients, and good outcomes (mrs score <(><<)> 2) occurred in 7 (41.2%).The mean length of stay was 11.6 ± 12.2 days.  the article does not state any technical issues during use of the solitaire fr, react catheter, or onyx.  the following intra- or post-procedural outcomes were noted: 1.Postprocedural symptomatic ich occurred in 1 (5.9 %) patient 2.Periprocedural ich/sah occurred in 2 (11.8%) 3.Periprocedural vessel dissection occurred in 1 (5.9%) 4.Periprocedural vessel perforation occurred in 1 (5.9%) patient 5.Mortality occurred with 7 (41.2%) patients.

Manufacturer Narrative

Please refer to regulatory rep #: 2029214-2022-01666 for related information weinberg jh, sweid a, sajja k, abbas r, asada a, kosak o, mackenzie l, choe h, gooch mr, herial n, tjoumakaris s, zarzour h, rosenwasser rh, jabbour p.Posterior circulation tandem occlusions: classification and techniques.Clinical neurology and neurosurgery (2020), 198.Doi: https://doi.Org/10.1016/j.Clineuro.2020.106154.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NV MICROCATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15547920
• MDR Text Key: 301237079
• Report Number: 2029214-2022-01669
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-MICROCATH
• Device Catalogue Number: UNK-NV-MICROCATH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2022
• 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
• Patient Age: 56 YR
• Patient Sex: Male