MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Neurological Deficit/Dysfunction (1982); Paresis (1998); Therapeutic Response, Decreased (2271)

Event Date 01/14/2014

Event Type  Injury  

Manufacturer Narrative

Citation: louis j.Kim, farzana tariq, michael levitt, et al.¿multimodality treatment of complex unruptured cavernous and paraclinoid aneurysms¿ neurosurgery.Doi: 10.1227/neu.0000000000000192.The device was not returned for evaluation as it was implanted in the patient.Without return of the device we are unable to defectively determine the cause for the reported experience.The event occurred in the patient post procedure and its cause was unknown.Mdrs related to this report: 2029214-2017-00197, 2029214-2017-00198 and 2029214-2017-00199.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

Medtronic received information through review of literature that this patient (case 1) at six-week follow up, had a mile ptosis with resolution of diplopia and blurry vision.The patient returned to the hospital three months after treatment with worsening ptosis, headaches, and fixed and dilated pupil.The angiogram revealed progressive growth of the aneurysm and retraction of the pipeline into the lumen of the aneurysm (figure 1g and 1h).A second pipeline device was placed and balloon dilation of the pipeline was performed to ensure apposition.Stagnation of flow was noted at the end of the procedure.The patient developed a mild left sided hemiparesis two days post treatment.The mri showed multiple punctate areas of restricted diffusion in the left middle cerebral artery distributed.The patient was discharged home with outpatient physical therapy.At fourth month follow up, the patient had resolution of both the hemiparesis and 3rd nerve palsy.There was significant reduction of aneurysm size but with residual filling at the neck.

Manufacturer Narrative

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): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 6418947
• MDR Text Key: 70386207
• Report Number: 2029214-2017-00200
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR