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 Hemorrhage, Cerebral (1889); Paresis (1998)

Event Date 04/18/2017

Event Type  Injury  

Manufacturer Narrative

Brunozzi, d., shakur, s.F., hussein, a.E., charbel, f.T., <(>&<)> alaraj, a.(2017).Middle cerebral artery flow velocity increases more in patients with delayed intraparenchymal hemorrhage after pipeline.Journal of neurointerventional surgery, 10(3), 249-251.Doi:10.1136/neurintsurg-2017-013042 the pipeline devices will not be returned for evaluation as they remain implanted in the patients.Based on the provided information, there does not appear to have been any defect of the devices during use.The events occurred in the patients post-procedure and the causes could not be conclusively determined from the provided information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic literature review found reports of delayed ipsilateral intraparenchymal hemorrhage (diph) after pipeline placement.The purpose of this article was to assess middle cerebral artery (mca) flow velocity changes after pipeline embolization device (ped) deployment in order to better understand the pathophysiology of diph.The authors retrospectively reviewed 10 patients who underwent ped placement of aneurysms proximal to the internal carotid artery (ica) terminus.All 10 patients were female; the mean age was 52 years.The article states that two patients experienced diph after pipeline placement, both within 48 hours of the procedure: - one patient developed diph on post-procedure day 1; the hemorrhage was located in the parietal-occipital lobe, causing permanent left hemiplegia.- the second patient presented with diph on post-procedure day 2 and the hemorrhage involved the parietal lobe, resulting in permanent left side sensory loss.

• 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: 7448871
• MDR Text Key: 106137587
• Report Number: 2029214-2018-00312
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• 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?: Yes
• Date Manufacturer Received: 03/26/2018
• 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): Other