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 Paresis (1998); Speech Disorder (4415); Ischemia Stroke (4418)

Event Date 12/10/2023

Event Type  Injury  

Event Description

Goertz l, pflaeging m, gronemann c, et al.Aneurysm treatment with the pipeline vantage embolization device in retrospective evaluation: periprocedural results from the pipe-vader study.World neurosurgery.2024;183:e210-e217.Doi:10.1016/j.Wneu.2023.12.057.Medtronic literature review found a report of death, ischemic stroke with symptoms including hemiparesis, fine motor dysfunction, global aphasia, sensory aphasia, and in-stent stenosis, and inguinal hematoma in association with aneurysm embolization using the pipeline embolization device (ped), navien catheter, phenom 21 catheter, phenom 27 catheter, and rebar 27 catheter.The purpose of this article was to evaluate the procedural feasibility, safety, and efficacy of this device.  the authors reviewed 28 cases of patients treated for 31 aneurysm(s) using the pipeline embolization device, phenom 21, phenom 27, or rebar 27 catheters.Of the 28 patients, the average age was 57 years, 19 were female and 9 were male.Aneurysm morphology was saccular in 21 cases, lobulated in 4 cases, fusiform in 4 cases, blister like in 1 case and dissecting in 1 case.Five aneurysms were ruptured.The median aneurysm size was 5 mm and a median neck width of 3.2 mm.Four aneurysms were treated with more than one stent.The article does state balloon angioplasty was performed in two cases.Inadequate imaging occurred in 2 cases.In addition, two of the four patients that encountered a post procedural stroke discharged to a rehabilitation facility with a mrs score of 1.The following intra- or post-procedural outcomes were noted: global cerebral edema from the patients primary diagnosis of subarachnoid hemorrhage leading to death ischemic stroke occurred in 4 patients hemiparesis fine motor dysfunction global aphasia sensory aphasia in stent stenosis inguinal hematoma in 1 patient.

Manufacturer Narrative

Continuation of d10: product id unk-nv-ped3 (lot: unknown); product id unk-nv-rfx (lot: unknown); product id unk-nv-fg (lot: unknown); product id unk-nv-rebar (lot: unknown); product id unk-nv-ped3 (unknown); product type: ; implant date n/a; explant date n/a product id unk-nv-rfx (unknown); product type: ; implant date n/a; explant date n/a product id unk-nv-fg (unknown); product id unk-nv-rebar (unknown); product id unk-nv-ped3 (unknown); product type: ; implant date n/a; explant date n/a product id unk-nv-rfx (unknown); product id unk-nv-rebar (unknown).G2: citation: authors: goertz, lukas, muriel pflaeging, christian gronemann, david zopfs, jonathan kottlors, marc schlamann, franziska dorn, thomas liebig, and christoph kabbasch.Aneurysm treatment with the pipeline vantage embolization device in retrospective evaluation: periprocedural results from the pipe-vader study.Worl neurosurgery 183:e210-e217 2024.Doi:10.1016/j.Wneu.2023.12.057 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 submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 19180119
• MDR Text Key: 341057561
• Report Number: 2029214-2024-00743
• 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: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2024

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: 04/19/2024
• Initial Date FDA Received: 04/25/2024
• 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
• Treatment: SEE H11...
• Patient Outcome(s): Other