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

Model Number NV UNK PIPELINE

Device Problems Activation Failure (3270); Migration (4003)

Patient Problems Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2016

Event Type  malfunction  

Event Description

Kühn, a.L., wakhloo, a.K., gounis, m.J., kan, p., de macedo rodrigues, k., lozano, j.D., marosfoi, m.G., perras, m., brooks, c., howk, m.C., rex, d.E., massari, f., <(>&<)> puri, a.S.(2017).Use of self-expanding stents for better intracranial flow diverter wall apposition.Interventional neuroradiology¿: journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences, 23(2), 129¿136.Https://doi.Org/10.1177/1591019916681981 medtronic review of the literature article found described 5 cases in which pipeline devices were implanted for aneurysm treatment.In 3 of the cases wall apposition was inadequate.In 2 cases proximal migration occurred and was attributed to challenging patient anatomy.In all cases a non-medtronic self-expanding nitonol stents were subsequently deployed for improving wall apposition and jail the pipeline stents from further migration respectively.During one procedure, a clot developed after stent deployment and the patient was immediately treated successfully with glycoprotein iib/iiia inhibitor.One patient had the pipeline implanted to cover 2 aneurysms and during follow-up one of the aneurysm was noted to have "near complete occlusion." no additional symptoms/issues, treatment, or complications were noted related to the incomplete aneurysm occlusion.

Manufacturer Narrative

Reported patient age is representative of the mean age of all patients included in the reported information in the literature article.Reported patient sex is representative of the majority of patients included in the literature article.3/5 patients were female.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
• MDR Report Key: 12439385
• MDR Text Key: 281029497
• Report Number: 2029214-2021-01124
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• 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
• Date Manufacturer Received: 08/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR