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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number UNK-NV-PED3
Device Problems Retraction Problem (1536); Unintended Movement (3026); Activation Failure (3270); Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/20/2021
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
Dominik f vollherbst, h saruhan cekirge, isil saatci, feyyaz baltacioglu, baran onal, osman koc, riitta rautio, matias sinisalo, al ejandro tomasello, pedro vega, mario martínez-galdámez, jeremy lynch; journal of neurointervent surgery; 2022; 0:1¿7; first clinical multicenter experience with the new pipeline vantage flow diverter; doi:10. 1136/neurintsurg-2021-018480 medtronic received information in a literature article that patient's treated with a ped3 pipeline had complications.  the aim of this multicenter study was to assess the periprocedural safety and feasibility, as well as the short-term efficacy, of the new pipeline vantage (pv) flow diverter (fd) for the treatment of intracranial aneurysms. Patients with intracranial aneurysms, who were treated with the pv between january 2020 and june 2020, were systematically reviewed.  sixty patients with 70 aneurysms were included in this study.  the mean age of the patients was 53. 9 years.  forty-one patients were female. The pre-, peri- and post-procedural antiplatelet therapy, as well as the testing of thrombocyte aggregation response, were performed according to the respective institutional standards.  the recommended delivery systems are the phenom 21 and the phenom 27 microcatheter. Recapturing or repositioning of the pv, because of suboptimal positioning of the initially implanted device, was performed in 27. 9% of the treatments. Additional coiling was performed in 18. 6% for the following reasons: large size (46. 2%), operator¿s choice (30. 8%), acute pre-interventional aneurysmal hemorrhage (7. 7%), and irregular shape (7. 7%). In-stent balloon angioplasty was performed to enhance the vessel wall apposition in 24. 6%.  the ease of deployment was rated ¿good¿ or ¿very good¿ in 88. 5% of the cases, while in 6. 6% it was rated ¿intermediate¿ , and ¿poor¿ in only 4. 9%. Vessel wall apposition was rated ¿very good¿ or ¿good¿ in 95. 1% and ¿intermediate¿ in 4. 9%, while it was not rated ¿poor¿ or ¿very poor¿ in any case.  procedural technical complications occurred in 15 out of 61 treatments (24. 6%). The most frequent technical complication (12/15; 19. 7% of all treatments) was hang-up of the fd on the pusher wire at the proximal part of the interface between the fd and the pusher wire, so that the fd could not be released as intended. In all of these cases, the fd could be finally released by applying repetitive gentle push and/or pull on the pusher wire.  in four cases, the hang-up was severe, so that several attempts and more force were necessary to release the fd. In one of these cases, during the treatment of an 11 mm sidewall aneurysm of the internal carotid artery (ica), this manipulation led to a pull back of the pv at the level of the neck of the aneurysm, so that a second pv of the same size had to be placed. In another treatment, without hang-up of the fd, there was insufficient vessel wall apposition at the proximal part of the pv and a neuroform atlas stent was additionally implanted to improve the apposition.  the other technical complications were displacement of the fd when navigating the microcatheter through it, and a high resistance when pushing the fd through the microcatheter which led to breaking of the proximal part of the microcatheter.  all of these technical complications were successfully managed and did not cause any clinical consequences. No periprocedural thrombotic complications occurred. A non-device related procedural symptomatic complication, an anaphylactic allergic reaction, occurred in one treatment (1. 6%) and was successfully overcome with medical treatment.  post-procedural symptomatic complications occurred after four treatments (6. 6%), of which only one was directly related to the implanted fd. One patient developed small brain stem and midbrain infarctions, most likely due to the occlusion of perforator arteries, after the implantation of five pvs into the basilar and posterior cerebral artery for the treatment of a multisegmental aneurysmal disease, leading to a stroke (national institutes of health stroke scale (nihss) 5).  the two other complications were a puncture site bleeding which needed surgical intervention and a urinary tract infection during the hospital stay which resolved after administration of antibiotics.  deterioration of mrs (compared with the pre-interventional scale) was observed in two patients.  in-stent stenosis or occlusion was observed after 13 treatments (21. 3%) and was graded as ¿mild¿ in 12/13 cases (92. 3%).  in one case (1. 6%), a complete, asymptomatic occlusion of a pv implanted into the mca for the treatment of a fusiform mca bifurcation aneurysm, which was completely occluded in the follow-up imaging, was observed.
 
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Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
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 Key13783803
MDR Text Key297221445
Report Number2029214-2022-00417
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 03/15/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNK-NV-PED3
Device Catalogue NumberUNK-NV-PED3
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/06/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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