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Model Number PED-425-25
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems Fistula (1862); Ischemia (1942); Blurred Vision (2137)
Event Date 02/18/2019
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 does not appear to have been any defect of the device during use. The event occurred in the patient post-procedure and its cause could not be conclusively determined from the reported information. If information is provided in the future, a supplemental report will be issued.
Event Description
Medtronic received information through clinical study that the aneurysm ruptured after successful device placement. On (b)(6) 2019, the patient underwent the implantation of a ped-425-25 stent in the intracavernous segment of the right carotid siphon, covering the ostium of the large intracavernous aneurysm with symptomatic diplopia. Final check, the stent appeared to be well positioned, with the discrete stasis of contrast medium in the aneurysmal sac. On (b)(6) 2019, the patient reported the onset of exacerbated diplopia, associated with chemosis, exophthalmos, and progressively worsening periorbital edema. On (b)(6) 2019, the patient presented at the er, where a brain ct and brain mri scans revealed, the presence of a right carotid¿cavernous fistula draining into the upper ipsilateral ophthalmic vein. Angiography confirmed the presence of a right carotid¿cavernous fistula, due to the rupture of the known ipsilateral giant intracavernous aneurysm. The fistula was draining into the upper right ophthalmic vein, and from there into both facial veins; minimal to mild opacification of the inferior petrosal sinus on the left, with no draining into the inferior right petrosal sinus. Given the presence of the flow-diverter stent positioned in the intracavernous segment, the fistula was inaccessible from the arterial side. On (b)(6) 2019, it was decided to perform endovascular treatment. Under general anesthesia, a diagnostic catheter was introduced via left transfemoral arterial access into the right internal carotid artery. Via an approach through the right transfemoral vein, using a coaxial system comprising an arrow 6 f introducer sheath with an envoy 6 f guide catheter, catheterization of the right inferior petrosal sinus was performed to reach the cavernous sinus at the point immediately proximal to the root of the ipsilateral superior ophthalmic vein, in order to occlude the fistula using coiling. Despite numerous attempts, it did not prove possible to reach a satisfactory position with a microcatheter and to perform the procedure. It was then decided to shift the system over to the left jugular vein, positioning it at the distal end of the origin of the ipsilateral inferior petrosal sinus. Even the attempts made using this approach failed in reaching the desired position between the cavernous sinus and the final segment of the right ophthalmic vein. It was therefore decided to try via the right facial vein, and catheterization was performed using a syphontrak. 060 intermediate catheter. However, given the presence of a fine venous plexus that did not permit the passage of the micro-guide and microcatheter, the procedures performed from the area of the torcula did not allow for the successful accomplishment of the catheterization. It was decided to suspend the procedure. After further discussion with an ophthalmologist and a maxillofacial surgeon, it was decided to place two more flow-diverter stents inside the first one, to reduce the flow into the fistula and to contribute to a hypothetical occlusion. With the patient under systemic heparinization (act x 2), via percutaneous right transfemoral arterial access, at the extreme distal end of the intrapetrous segment of the right internal carotid artery. A marksman over a traxcess 0. 014, was used to the catheterization of the m1 segment of the middle right cerebral artery was performed, covering the ostium of the aneurysm from which originated the arterial-venous shunt, which was overlapped with the one implanted earlier, using a pipeline 4. 25 x 16 mm flow-diverter stent and obtaining correct positioning. The procedure was repeated by placing an additional pipeline 4. 25 x 20 mm stent overlapping and completely covering the earlier one. The final checks indicated the correct placement of the implant, with the presence of a doubtful increase in contrast stasis in the aneurysmal sac. No distal vascular stop. The 8 f introducer sheath was left in place in the right groin area. However, this procedure was only partially successful, resulting in only a moderate reduction in the right-side edema and exophthalmos. On (b)(6) 2019, following an ophthalmic examination and the discussion of the case, the indication arose for renewed treatment via surgical exposure of the superior ophthalmic vein and the subsequent coiling of the cavernous sinus. Catheterization of the right cavernous sinus with a 0. 010 silver speed microguide, and the placement of an echelon 10 microcatheter in the cavernous sinus were then performed. Coils detached by electrolysis were subsequently implanted until the fistula was occluded. Final checks indicated the occlusion of the carotid-cavernous fistula. No distal vascular stop.
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Manufacturer (Section D)
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
9775 toledo way
irvine CA 92618
Manufacturer Contact
glen belmer
9775 toledo way
irvine, CA 92618
MDR Report Key8556213
MDR Text Key143391390
Report Number2029214-2019-00379
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/20/2020
Device Model NumberPED-425-25
Device Catalogue NumberPED-425-25
Device Lot NumberA479405
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/10/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/21/2017
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: 04/26/2019 Patient Sequence Number: 1