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 Hematoma (1884); Intracranial Hemorrhage (1891); Neuropathy (1983); Transient Ischemic Attack (2109); Ischemia Stroke (4418); Retroperitoneal Hemorrhage (4483)

Event Date 12/21/2022

Event Type  Injury  

Event Description

Vranic, j.E., harker, p., stapleton, c.J., regenhardt, r.W., dmytriw, a.A., doron, o.M., alotaibi, n.M., leslie-mazwi, t.M., gupta, r., berglar, i.K., tan, c.O., koch, m.J., raymond, s.B., mascitelli, j.R., patterson, t.T., seinfeld, j., white, a., case, d., roark, c., patel, a.B.(2023).The impact of dual antiplatelet therapy duration on unruptured aneurysm occlusion after flow diversion: a multicenter study.Journal of computer assisted tomography.Https://doi.Org/10.1097/rct.0000000000001457 medtronic literature review found a report of intracranial hemorrhage, ischemic stroke, in-stent stenosis, transient ischemic attack (tia), compressive neuropathy, retroperitoneal hematoma, and groin hematoma in association with pipeline flow diversion treatment.The purpose of this article was to assess the impact that the type and duration of dual antiplatelet therapy (dapt) has on aneurysm occlusion rates and iatrogenic complications after flow diversion.  the authors reviewed 205 cases of patients treated for aneurysms using a single pipeline embolization device (ped) and dapt.Of the 205 patients, the average age was 54 years, were 177 female and 28 were male.Two groups were formed to trial the duration of dapt and the significance it has on aneurysm occlusion post pipeline placement.One group (151 patients) were given dapt for less than 6 months post pipeline placement and the other group (54 patients) were given dapt for more than 6 months post pipeline placement.Overall, there was a statistical significant difference in the duration of dapt and aneurysmal occlusion post pipeline placement.The patients in the dapt given for longer than 6 months were found to take significantly longer to occlude the aneurysm or not occlude the aneurysm at all.Therefore, the authors recommended treating future patients with dapt for less than 6 months to successfully occlude the aneurysm post pipeline placement.The article does not state any technical issues during use of the pipeline, marksman catheter, or phenom catheter.At follow up 26 a neurysms remained nonoccluded.The following intra- or post-procedural outcomes were noted: intracranial hemorrhage occurred in 5 cases (4 in dapt >6 month group and 1 in dapt >6 month group) ischemic stroke occurred in 1 case (dapt >6 month group) in- stent stenosis occurred in 2 cases (1 in each group) transient ischemic attack in 2 cases (dapt >6month group) compressive neuropathy in 1 case (dapt >6 month group) retroperitoneal hematoma in 3 cases (dapt >6 month group) groin hematoma in 2 cases ( dapt >6 month group).

Manufacturer Narrative

Concomitant medical product: product id nv unk pipeline (unknown); product type: ; implant date n/a; explant date n/a product id unk-nv-marksman (unknown); product type: ; implant date n/a; explant date n/a g2: citation: authors: vranic, j.E., harker, p., stapleton, c.J., regenhardt, r.W., dmytriw, a.A., doron, o.M., alotaibi, n.M., leslie-mazwi, t.M., gupta, r., berglar, i.K., tan, c.O., koch, m.J., raymond, s.B.,.The impact of dual antiplatelet therapy duration on unruptured aneurysm occlusion after flow diversion: a multicenter study.Journal of computer assisted tomography.2023.Https://doi.Org/10.1097/rct.000000000000 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: 18378066
• MDR Text Key: 331183548
• Report Number: 2029214-2023-02429
• 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: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• 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
• Date Manufacturer Received: 12/05/2023
• 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