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

Model Number NV UNK PIPELINE

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problems Aneurysm (1708); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event indicates article was published in the journal in september 2020.The exact date of publication was not specified.Procedures were completed between 2014 and 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

Cho, d.Y., choi, j.H., choi, h.S., kim, b., & shin, y.S.(2020).Immediate postoperative angiographic stagnation of contrast media and t2-weighted magnetic resonance imaging features within aneurysmal sac are associated with early regression of large or giant aneurysm after flow diversion only. world neurosurgery, 141, e151¿e159.Https://doi.Org/10.1016/j.Wneu.2020.05.047 medtronic review of the literature article found 30 cases analyzed post-operatively with 3-6 months follow-up after implantation of pipeline embolization devices to treat cerebral aneurysms.The purpose of the study was to compare the imaging features from digital subtraction angiography (dsa) and spin echo t2-weighted magnetic resonance imaging (mri) between patients with early total regression and those with partial regression.All cases except 1 were considered successful.The single case that was considered to not be successful was because of incomplete apposition due to the stent kinking.Kinking also occurred in 3 other cases that were considered to be successful.Foreshortening was observed in 7 cases intra-operatively and for all cases with foreshortening, an additional pipeline was placed.5 cases required a balloon to assist with wall apposition.Of the 30 patients included in the study, 10 showed only partial occlusion or aneurysm regression in the 3-6 month follow-up.These results were based on observation of the percent area of iodine stagnation dsa and measurement of the entire volume of the aneurysm sac in mri.It should be noted that contradictory information was seen in the article.Though the article states more than once that 20 patients had total or near total regression and 10 had partial regression, the information in table 1 is contradictory - indicating that 10 patients had total or near total regression and 20 had partial regression.

• 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: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 12159010
• MDR Text Key: 261298859
• Report Number: 2029214-2021-00853
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2021
• 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