MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Infarction, Cerebral (1771); Paresis (1998)

Event Date 03/01/2016

Event Type  Injury  

Manufacturer Narrative

The pipeline device will not be returned for evaluation as it was implanted in the patient.Based on the reported information, there did not appear to have been any defect of the device during use.Stroke is a known inherent risk of pipeline procedure and is documented in the pipeline instruction for use.Per the article, the exact mechanism of ischemic stroke is unclear.Kim, s.O.(2016, march).Delayed ischemic stroke after flow diversion of large posterior communicating artery aneurysm.Journal of cerebrovascular and endovascular neurosurgery j cerebrovasc endovasc neurosurg, 18(1), 19.Doi:10.7461/jcen.2016.18.1.19.

Event Description

Medtronic received information from literature review that a patient experienced ischemic stroke after pipeline implantation.The patient received the pipeline implant to treat a wide-necked aneurysm in the left posterior communicating artery (pcoa).The aneurysm had a neck width of 11mm, length of 18mm, and neck of 9mm.Deployment of the pipeline was considered successful.Post-operative angiography showed that whole branch vessels were not interrupted.The patient was discharged two days post-procedure with no neurological deficit.The patient was prescribed dapt (clopidogrel 75mg, aspirin 100mg daily).Twenty-five days after implant, the patient suddenly presented intermittent right hemiparesis.It should be noted that the patient already had right hemiparesis due to cerebral palsy (mrs of 2), but was readmitted to the hospital.Diffusion mri did not show any ischemic stroke.Angiography was recommended, which the patient refused.The patient remained on dapt without additional medication and was closely observed in the hospital.The patient continued to report more frequent and worsening hemiparesis; mrs increased to 4.A second diffusion mri was taken 27 days after implant.Ischemic stroke in the left anterior choroidal artery (acha) was observed.Angiography was recommended, which the patient again refused.The patient remained on dapt without additional medication and was transferred to rehabilitation.The patient was discharged 83 days after pipeline implant with mrs improved to 3.The physician reports that the exact mechanism leading to ischemic stroke is unclear.

Manufacturer Narrative

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

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 5740008
• MDR Text Key: 47892139
• Report Number: 2029214-2016-00418
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2016
• 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 Outcome(s): Disability
• Patient Age: 56 YR