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

Model Number NV UNK FLEX

Device Problem Unintended Movement (3026)

Patient Problem Pain (1994)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Diestro, j.D.B., parra-farinas, c., zetchi, m.A., spears, j., <(>&<)> marotta, t.R.(2020).The pop (pull on pipe) maneuver: a technical note for rescuing a prolapsed pipeline device.Journal of stroke and cerebrovascular diseases, 29(4).Https://doi.Org/10.10 16/j.Jstrokecerebrovasdis.2020.104647.Medtronic review of the literature article found described a case in which, when retrieving the pipeline embolization device (ped) pushwire, there was shortening of the proximal end of the ped stent resulting in prolapse of the ped stent into the aneurysm.The "pull on pipe (pop)" maneuver was utilized to address the prolapse of the first ped.A second ped was deployed inside the lumen of the prolapsed ped with gentle traction to restore the initial flow diverter into its proper position.The maneuver also allows for the immediate deployment of the second ped to improve proximal purchase and overall construct stability.The second ped was then completely deployed proximally.Final cerebral angiograms and cone beam computed tomography (ct) demonstrated adequate positioning and wall apposition of both peds and beginning aneurysmal flow stasis.The patient was undergoing a procedure for flow diversion treatment of a giant aneurysm of the right internal carotid artery (ica) cavernous sinus segment.The patient had symptoms of seizures, diplopia on rightward gaze, right eye ptosis and miosis, and limited abduction of right side - findings consistent with right cranial nerve 6 palsy and accompanying horner's syndrome.Post-operatively, the patient experienced transient severe right eye pain for the first month which was alleviated with an initial course of dexamethasone and pain medication.Neuroimaging at 4 months post-operative showed marked regression of aneurysm filling and the patient's cranialnerve symptoms were notably improved from pre-operative status.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• 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: 13448030
• MDR Text Key: 294664849
• Report Number: 2029214-2022-00156
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NV UNK FLEX
• Device Catalogue Number: NV UNK FLEX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2022
• 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 Age: 21 YR
• Patient Sex: Male