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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

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COVIDIEN (IRVINE) PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-500-30
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fistula (1862); Neurological Deficit/Dysfunction (1982)
Event Date 04/28/2017
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis as it was successfully implanted on the patient. The events reported occurred six weeks post the embolization procedure and its exact cause remains unknown. All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture. Based on the reported information, there was no reasonably suggestion that a malfunction or quality deficiency of the device occurred during the treatment procedure. Based on the reported information, there is no evidence suggesting that the device was defective, but rather a post procedure and patient conditional related event. Linked events: 2029214-2018-00300, 2029214-2018-00301, 2029214-2018-00302. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report through literature review of " transvenous aneurysm sac and rupture point coil embolization of direct carotid cavernous fistula after pipeline embolization". The postoperative course was uneventful and uneventful embolization procedure, the patient was discharged at the neurological baseline 10 days after the procedure with the same dapt regimen. Six weeks after the ped embolization, the patient suffered a sudden onset of a severe headache following pulsatile tinnitus and progressive worsening of the right visual acuity without any head injuries. Dsa images showed the development of a right direct carotid cavernous fistula (dccf) that drained into the right superior ophthalmic vein, the pterygoid venous plexus, the inferior petrosal sinus, the superior petrosal sinus, and via the intercavernous sinus into the contralateral cavernous sinus (cs). It was determined from the balloon occlusion test (bot) that the patient could not tolerate a permanent carotid occlusion, a transvenous coil embolization was indicated as a treatment option to preserve the ica flow. Under general anesthesia and systemic heparinization, a 4f diagnostic catheter was inserted into the right ica via the left femoral artery sheath to provide a roadmap guidance and control angiography. After the 6f sheath was introduced in the right common femoral vein, the tip of the 4f inner catheter coaxially assembled with the 6f guiding catheter was cannulated into the origin of the right inferior petrosal sinus via the internal jugular vein. A excelsior sl-10 (stryker) was advanced into the cs and further inserted into the aneurysm sac via the rupture point with the assistance of the microguidewire. After the aneurysm sac was embolized with some coils, the microcatheter was pulled back into the cs, and a few coils were put into the part of the cs adjacent to the rupture point for complete occlusion. Post-treatment dsa images showed complete resolution of the dccf with aneurysm sac occlusion. Pulsatile tinnitus disappeared and the right visual acuity gradually improved. The patient was discharged with the same dapt regimen. An (b)(6) female complained of double vision due to a right incomplete oculomotor nerve palsy. Magnetic resonance imaging showed a right carotid cavernous aneurysm. She was nonsmoker, and had no history of hypertension. Digital subtraction angiography (dsa) images confirmed the aneurysm measuring 20 mm in diameter. The patient was given dual antiplatelet therapy (dapt) on aspirin 100 mg/d and clopidogrel 50 mg/d 10 days prior to the procedure. Platelet activity measured by verifynow assays within 12 hours before the intervention showed aspirin reaction units 460 p2y12 reaction units 135. Under general anesthesia and systemic heparinization, a 7 french (f) long sheath was placed in the right internal carotid artery (ica) via femoral artery puncture. A navien 5f catheter was placed in the petrous segment of the ica and a marksman was introduced into the right m1 segment with the assistance of a guidewire. Three peds were telescopically deployed. Post treatment dsa images showed significant contrast stasis within the aneurysm. The postoperative course was uneventful, and the patient was discharged at the neurological baseline 10 days after the procedure with the same dapt regimen. Six weeks after the ped embolization, the patient suffered a sudden onset of a severe headache following pulsatile tinnitus and progressive worsening of the right visual acuity without any head injuries. Dsa images showed the development of a right direct carotid cavernous fistula (dccf) that drained into the right superior ophthalmic vein, the pterygoid venous plexus, the inferior petrosal sinus, the supe¬rior petrosal sinus, and via the intercavernous sinus into the contralateral cavernous sinus (cs). It was determined from the balloon occlusion test (bot) that the patient could not tolerate a permanent carotid occlusion, a transvenous coil embolization was indicated as a treatment option to preserve the icaflow. Under general anesthesia and systemic heparinization, a 4f diagnostic catheter was inserted into the right ica via the left femoral artery sheath to provide a roadmap guidance and control angiography. After the 6f sheath was introduced in the right common femoral vein, the tip of the 4f inner catheter coaxially assembled with the 6f guiding catheter was cannulated into the origin of the right inferior petrosal sinus via the internal jugular vein. A excel sior sl-10 (stryker) was advanced into the cs and further inserted into the aneurysm sac via the rupture point with the assistance of the microguidewire. After the aneurysm sac was embolized with some coils, the microcatheter was pulled back into the cs, and a few coils were put into the part of the cs adjacent to the rupture point for complete occlusion. Post-treatment dsa images showed complete resolution of the dccf with aneurysm sac occlusion. Pulsatile tinnitus disappeared and the right visual acuity gradually improved. The patient was discharged with the same dapt regimen. Flow diverters disrupt the blood flow into the aneurysm sac and promote thrombosis while preserving the surrounding small vessels and perforators. Ped is the most common flow diverter which has recently been approved in (b)(6) for large/giant unruptured or chronic ruptured aneurysms arising between the petrous and the superior hypophyseal artery segments of the ica. Because the ped embolization is a less invasive procedure that does not involve a craniotomy, it has been increasingly used by incorporating the patients¿ wishes. Although some reports have shown the effectiveness and safety, the delayed aneurysm rupture after ped embolization has beenknown as a rare but serious complication. The etiology of a delayed aneurysm rupture is unclear, but the fragile aneurysm wall in the setting of inflammation coupled with continuous arterial pressures is suspected. Some authors suggested that symptomatic large or giant aneurysms with high aspect ratio sac and/or inertia driven inflow carry a high risk of delayed rupture after ped embolization. Due to the anatomical specificity, the delayed rupture of carotid cavernous aneurysms cause dccfs. The ideal treatment of dccfs is to occlude the rupture point while preserving the ica flow. Although the transarterial or transvenous coil embolization of the affected cs has become a primary treatment, the transarterial approach is not feasible because the meticulous mesh of flow diverters prohibits the microcatheter passage. But transvenous embolization associated with the voluminous coil mass in the affected cs also carries the risk of permanent cranial nerve palsy in the cs. When the occlusion of the fistula while preserving the ica flow is not possible, the bot should be performed for the prediction of tolerance of a required permanent artery occlusion (pao). Patients who can tolerate a pao are indicated for the internal trapping of the ica, but those who cannot require vascular revascularization because of the high risk of ischemia. But dapt associated with flow diverter therapy is a possible cause of difficult hemostasis during vascular revascularization. In the present case, the microcatheter was inserted transvenously into the aneurysm sac through the rupture point. Coil embolization of both the aneurysm sac and a part of the cs adjacent to the rupture point could achieve not only the 19-immediate aneurysm occlusion but also the rupture point obliteration with a small amount of coil mass in the cs for preventing the newly developed or aggravated cranial nerve palsy due to the dense coil packing. Ped embolization of carotid cavernous aneurysms may cause dccfs due to a delayed aneurysm rupture. Transvenous aneurysm sac and rupture point coil embolization may be feasible and an ideal treatment option for immediate aneurysm occlusion and rupture point obliteration with a small amount of coil mass.
 
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Brand NamePIPELINE FLEX
Type of DeviceINTRACRANIAL 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
9492753836
MDR Report Key7444979
MDR Text Key106011516
Report Number2029214-2018-00302
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 04/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED-500-30
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 Received03/26/2018
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: 04/19/2018 Patient Sequence Number: 1
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