MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 UNKNOWN SOLITAIRE; CATHETER, THROMBUS RETRIEVER

Model Number UNK-NV-SOLITAIRE

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

Patient Problems Intracranial Hemorrhage (1891); Perforation of Vessels (2135); Vascular Dissection (3160)

Event Date 07/18/2016

Event Type  Death  

Manufacturer Narrative

Event related to regulatory report #: 2029214-2023-00162 see literature article.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

P bhogal, r martinez moreno, o ganslandt, h bäzner, h henkes, and m aguilar perez; journal of neurointerventional surgery; 2017; 9:283¿289; use of flow diverters in the treatment of unruptured saccular aneurysms of the anterior cerebral artery; doi:10.1136/neurintsurg-2016-012648.Medtronic received information in a literature article of patients treated with ped pipelines, solitaire stents, and possibly marksman catheters having complications.The purpose of the article was determine the efficacy of flow-diverting stents in the treatment of small, unruptured aneurysms of the anterior cerebral artery (aca).They retrospectively reviewed the available database of prospectively collected information for all patients treated with flow diversion for an unruptured saccular aneurysm of the aca between september 2009 and july 2016.In total 26 patients, with 27 aneurysms were identified that matched our inclusion criteria (11 male and 15 female).The average age of the patients was 59.3 years.All patients, except one, had a single aneurysm affecting the aca.  the average aneurysm fundus size was 2.9 mm.Procedure: all treatments were performed under general anesthesia.Two commercially available flow-diverting stents (fds) were used: ped (medtronic) and from a competing manufacturer. all patients received dual antiplatelet therapy. all procedures were performed via the right common femoral route using a 6 fr access system as standard and either a marksman catheter or a catheter from a competing manufacturer to deploy the fds. patency and flow characteristics within the aca and any cortical branches were assessed angiographically immediately after placement of the fds and during follow-up.Results: delivery of the flow diverter was possible in all cases.Adjunctive devices were used for six aneurysms¿four had coils and two patients had stents. of all patients with at least one follow-up angiogram 16 aneurysms were completely occluded and one patient had a minor remnant.All covered branches remained patent at follow-up.A single death was seen in the series.The patient was treated with one ped and a solitaire.In this patient a left a1/a2 aneurysm had previously been coiled after a subarachnoid hemorrhage.Follow-up dsa showed a progressive reperfusion of the aneurysm.Catheterization of, and flow diverter deployment, into the left aca were straightforward.Dsa thereafter revealed a wire dissection of the left pericallosal artery, with a minor leakage.The perforated vessel was occluded with glue, with an instantaneous interruption of the extravasation.During the following night, the patient deteriorated clinically and ct showed a massive intracranial hemorrhage (ich), which eventually caused the death of this patient.

• Brand Name: UNKNOWN SOLITAIRE
• Type of Device: CATHETER, THROMBUS RETRIEVER
• 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: 16288291
• MDR Text Key: 308700689
• Report Number: 2029214-2023-00163
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: GG
• 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: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• 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: 01/26/2023
• 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): Death
• Patient Age: 59 YR
• Patient Sex: Female