• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Model Number PED-375-18
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Neurological Deficit/Dysfunction (1982)
Event Type  Injury  
Manufacturer Narrative
Based on the reported information, there is no evidence suggesting that the device was defective, but rather a post procedure related event. The exact cause of the reported event is unknown. Since the device was not returned, we are unable to perform further root cause analysis. All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture. If information is provided in the future, a supplemental report will be issued.
Event Description
Medtronic received the following event: ¿delayed neurological deficits after endovascular placement of a pipeline embolisation device: clinical manifestation and treatment¿ (naveen sablani, maryam mumtaz hasan, ashik shrestha, jeffrey farkas) case presentation: a middle-aged woman with a medical history of hypothyroidism, rheumatoid arthritis (ra) on maintenance methotrexate and history of breast cancer treated with a mastectomy presented to the office with a complaint of chronic headaches associated with mild visual changes that had been worsening recently. On ct scan, she was found to have a 7 mm wide-neck, supraclinoid right internal carotid artery (ica) aneurysm. She was scheduled for elective treatment of the aneurysm with placement of a ped. On the day of the procedure, the right femoral artery was accessed using a 5 french (fr) sheath, through which a 5 fr davis catheter was introduced over 0. 035 terumo guidewire for the diagnostic portion of the procedure. Once the aneurysm was identified and the anatomy delineated on fluoroscopy, the diagnostic davis catheter and sheath were removed over an amplatz wire. Then a neuron max 0. 088 inch guide sheath was advanced over the amplatz wire to the right ica. A navien 0. 054¿ intermediary support catheter was advanced into the supraclinoid right ica, through which a marksman microcatheter was deployed. However, the procedure operators had difficulty getting the marksman microcatheter past the aneurysm neck. An attempt was made with the help of synchro 0. 014 inch guidewire without success. An asahi 0. 010 inch hydrophilic wire was then tried with the same result. A combination of both wires was then successfully used to advance the marksman microcatheter through the supraclinoid ica into the distal middle cerebral artery. A 3. 75×18 mm pipeline flow diverter device was then successfully deployed in the vessel with good positioning on fluoroscopy. The right ica remained patent without any evidence of stenosis. A follow-up ct scan of the head showed no hemorrhage or ischemic changes, and she had an uncomplicated hospital stay post procedurally. She was discharged on dual antiplatelet therapy. At her 2-week follow-up appointment, the patient complained of severe right-sided headaches that had been going on for 3 days. She described her headache as being persistent, sharp and a 10 out of 10 in severity. Her headaches were associated with nausea, photophobia, phonophobia, left hand and leg weakness with numbness, and a tingling sensation of her left lower extremities. Her neurological exam during the office visit was unremarkable, with stable vital signs. She was referred to the emergency room for an urgent non-contrast ct head, which showed a non-specific, faint, low-density area in the right frontal lobe. There was concern that she may have been experiencing ischemic symptoms from stenosis of the ped. A ct angiogram of the head and neck was done, which showed a patent ped device, with good flow and no ischemic or hemorrhagic changes. The patient was given zofran, reglan and fioricet in the emergency department with resolution of symptoms and was discharged with a diagnosis of migraine, along with orders for an outpatient mri. Her outpatient brain mri without contrast showed multiple areas of abnormal signal within the subcortical white matter at the right frontal, parietal, occipital and temporal lobes, with vasogenic edema and negative diffusion restriction. Given the mri findings she was asked to return to the hospital the same day for admission and further work-up. She also reported on the phone that her symptoms were progressing. Her vital signs during the admission were stable. Basic laboratory values and rheumatological markers were unremarkable. Her neurological exam was significant for left upper and lower extremity weakness, with 4 out of 5 on strength testing, as compared with 5 out of 5 strength in her right upper and lower extremities. She also exhibited decreased sensory perception on her left side in comparison with her right. Cranial nerves were intact and there were no meningeal signs. An mri with contrast was performed in the hospital; the t1 post contrast sequences showedmultiple, rounded, enhancing foci at the right frontal, parietal, temporal and occipital regions. Differential diagnosis: a shower of foreign body emboli was among the top differentials being considered given the patient¿s clinical presentation and brain mri with contrast, which showed significant enhancing lesions in the distribution of the vascular territory of the catheterized arteries with perilesional edema. There was no diffusion restriction suggestive of ischemic events. She was afebrile with unremarkable labs and no meningeal signs. Her indolent presentation made an infectious aetiology unlikely, and as such a lumbar puncture was not deemed necessary; however, cerebritis was considered a differential diagnosis. A diagnosis of complex migraines was also considered, although was less likely given neurological deficits on physical exam during this hospitalization. Treatment: she was treated with a high dose of methylprednisolone 250 mg intravenously every 6 hours for 1 day, with marked symptomatic improvement in her headaches and left-sided weakness and paresthesia, and then was switched to prednisone 30 mg daily, which was slowly tapered over a course of 2 months. Outcome and follow-up: after a day of methylprednisolone, our patient had marked symptomatic improvement in her headaches, left-sided weakness and paresthesia. Two follow-up mris with and without contrast showed near-complete resolution of the enhancing lesions. Several attempts were made before the final catheter was successfully positioned for deployment of the ped, which involvedtwisting and sliding maneuvers. This could have potentially caused the hydrophilic coating to dislodge and embolize to the cortical-subcortical areas distally in the vascular territory of the catheterized arteries. Our patient did not have an acute infarct or hemorrhage but developed a diffuse inflammatory reaction that involved the white matter ipsilateral to the ped deployment site. Highlighted that this presentation developed over time with improvement in patients¿ symptoms and near-resolution of enhancing lesions on mri after treatment with steroids. The patient had a history of ra and hypothyroidism, and therefore may be predisposed to autoimmune phenomena, which may also respond to a course of steroids.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Manufacturer (Section D)
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
9775 toledo way
irvine CA 92618
Manufacturer Contact
katcha taylor
9775 toledo way
irvine, CA 92618
MDR Report Key8775706
MDR Text Key150557660
Report Number2029214-2019-00708
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 07/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED-375-18
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/10/2019 Patient Sequence Number: 1