MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR UNKNOWN SOLITAIRE; CATHETER, THROMBUS RETRIEVER

Model Number UNK-NV-SOLITAIRE

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

Patient Problems Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Date 01/01/2018

Event Type  Injury  

Event Description

Ji won nam, na young jung, eun suk park, soon chan kwon.Aspiration-retriever technique for stroke with large bore intermediate catheter : a single center experience.Journal of korean neurosurg soc.2021, 732-739.Https://doi.Org/10.3340/jkns.2020.0308.   the purpose of this article was to achieve successful recanalization by a combined mechanical thrombectomy technique, the aspiration-retriever technique for stroke (arts), which is composed of a flexible large lumen distal access catheter and a retrievable stent as the firstline strategy of mechanical thrombectomy.There were 27 patients, 12 were female and 15 were male.The average age was 59 years.   the successful recanalization rate was 96% (n=26) while the fpe rate was 41% (n=11).The mean post-procedural nihss change was -3.0.Thirteen patients (48%) showed good clinical outcomes after thrombectomy with the arts technique (mrs at 90 days =2).Postoperative complications occurred in seven of 25 patients : hemorrhagic transformation in six patients (22%) and distal embolization in one patient (4%).Mortality was 15% (n=4).   the following intra- or post-procedural outcomes related to the medtronic pipeline were noted:  1.Hemorrhagic transformation,   2.Distal embolization,  3.Mortality.

Manufacturer Narrative

Ji won nam, na young jung, eun suk park, soon chan kwon.Aspiration-retriever technique for stroke with large bore intermediate catheter : a single center experience.Journal of korean neurosurg soc.2021, 732-739.Https://doi.Org/10.3340/jkns.2020.0308.  refer to regulatory rep #: 2029214-2022-01100 for related event information.Age: 59 years is the average age of the patients who used pipeline devices in the study.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: UNKNOWN SOLITAIRE
• Type of Device: CATHETER, THROMBUS RETRIEVER
• 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 ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 14916263
• MDR Text Key: 295249795
• Report Number: 2029214-2022-01103
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-SOLITAIRE
• Device Catalogue Number: UNK-NV-SOLITAIRE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2022
• 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: 59 YR
• Patient Sex: Male