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

Model Number UNK-NV-FG

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

Patient Problems Hemorrhage/Bleeding (1888); Vasoconstriction (2126); Stenosis (2263); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)

Event Date 07/11/2023

Event Type  Injury  

Event Description

El naamani, k., mastorakos, p., yudkoff, c.J., abbas, r., tjoumakaris, s.I., gooch, m.R., herial, n.A., rosenwasser, r.H., zarzour, h., schmidt, r.F., & jabbour, p.M.(2023).Comparison of ped/ped flex and ped shield in the treatment of unruptured intracerebral aneurysms.Journal of neurosurgery, 1¿5.Https://doi.Org/10.3171/2023.7.Jns23981 medtronic literature review found reported outcomes of vasospasm, stroke, hemorrhage, thrombus formation, and in stent stenosis at midterm follow up in association with pipeline flex and pipeline flex shield flow diversion.Ultimately, the review found no significant difference in using the pipeline flex vs.Pipeline flex shield when assessing efficacy, outcomes, length of stay, or complication rates.The purpose of this article was to compare two devices, the pipeline flex and the pipeline flex with shield technology in the efficacy and safety of aneurysm flow diverter treatment.  the authors reviewed 200 cases of patients treated for non-ruptured aneurysms using the pipeline flex or pipeline flex shield.Of the 200 patients, the average age was 55 years, 163 were female and 37 were male.In all patients dual antiplatelet treatment was started 10 days prior to the procedure.  fifty patients were treated with the pipeline flex shield and 150 patients were treated with the pipeline flex.All pipeline devices were implanted using a phenom 27 microcatheter.  the article does state technical issues during use of the pipeline flex/pipeline flex shield including, migration of initial ped and inadequate neck coverage.There was no technical issue reported while using the phenom catheter.In addition, 191 patients had mrs scores from 0-2 at discharge and 9 patients had mrs scores of 3-6 at discharge.The following intra- or post-procedural outcomes were noted: 1.Vasospasms in 2 patients intraoperative with ped flex 2.Stroke in 2 patients intraoperative with ped flex and 9 patients periprocedural with ped flex and shield 3.Hemorrhage in 1 patient intraoperative with ped flex and 2 patients periprocedural with ped flex 4.Thrombus formation in 1 patient intraoperative with ped flex 5.In-stent stenosis in 24 patients at time of follow-up with ped flex and shield.

Manufacturer Narrative

Concomitant medical product: product id nv unk flex (unknown); product id nv unk pipeline (unknown); product type: ; g2: citation: authors: el naamani, k., mastorakos, p., yudkoff, c.J., abbas, r., tjoumakaris, s.I., gooch, m.R., herial, n.A., rosenwasser, r.H., zarzour, h., schmidt, r.F., & jabbour, p.M.Comparison of ped/ped flex and ped shield in the treatment of unruptured intracerebral aneurysms.Journal of neurosurgery 1-5 2023.Https://doi.Org/10.3171/2023.7.Jns23981 earliest date of publication used for date of event no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.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.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: PHENOM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 18097082
• MDR Text Key: 327697770
• Report Number: 2029214-2023-02182
• 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: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-FG
• Device Catalogue Number: UNK-NV-FG
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 11/08/2023
• 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