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

Model Number NV UNK PIPELINE

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2022

Event Type  Injury  

Event Description

Colasurdo, m., edhayan, g., taweel, a.A., barghash, m., kan, p., raghuram, k.The rationale behind transcirculation neuroendovascular interventions: literature review through a case-series approach.Operative neurosurgery.24:357¿367.2023.Doi: 10.1227/ons.00000 00000000540 summary: with the development of advanced endovascular techniques and materials, neurointerventionalists can perform challenging and complex cases that were previously difficult to perform.Transcirculation approaches could be a useful tool used incomplicated cases, providing access to the target vessel, through the contralateral or opposite circulation, when anterograde access is difficult or nonachievable.Objective: to retrospectively review cerebrovascular interventions performed through a transcirculation approach performed by staff at our institution.Methods: english-language studies, published until august 2022, reporting transcirculation interventions in the cerebrovascular circulation were retrospectively collected.Type of intervention, number of cases, rationale, and complications were analyzed.Furthermore, similar cases performed by staff currently at our institution were also reviewed and described.Results: including our cases, a total of 273 transcirculation treatment approaches have been reported.Intracranial aneurysm embolization, stroke thrombectomies, intra-arterial ophthalmic chemotherapy, arteriovenous malformationss, arteriovenous fistulas embol izations, and intracranial angioplasty and stenting are common indications.Reason for using a retrograde approach were stent/balloon¿assisted coiling of wide neck aneurysm in 116 cases, difficult angulation of branch in 91 cases, occlusion of parent vessel in 55 cases, and bailout/other in 11 cases.Conclusion: transcirculation approaches can be considered for cases where conventional anterograde treatment options are not feasible or as a bailout strategy in failed or complicated treatment attempts.They represent a strategy to consider when facing challenging cases, and if performed by experienced and dedicated neurointerventionalists, they can represent a safe alternative.Reported events: case 3: a patient with large 3 × 2-cm left cavernous ica aneurysm.During deployment of 2 overlapping pipeline embolization devices (peds¿medtronic neurovascular), the 2 peds became disconnected within the aneurysm on angioplasty, and distal access was lost.Immediately, a microcatheter and a wire were retrogradely navigated from the right ica through the acomm into the left ica (figure 3a).Simultaneously, a 6-mm snare through the left ica was then used to capture the microguidewire.Mca access was then re-established, and 2 additional peds (4.75 × 30 mm) were deployed to connect the disconnected devices.The patient was discharged on postprocedural day 2.

Manufacturer Narrative

Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.No specific device information received.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.

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL 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 Key: 17306941
• MDR Text Key: 319213896
• Report Number: 2029214-2023-01096
• Device Sequence Number: 1
• Product Code: OUT
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NV UNK PIPELINE
• Device Catalogue Number: NV UNK PIPELINE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2023
• 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