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Model Number FA-77450-18
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Fistula (1862)
Event Date 10/01/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Manufacturer Narrative
The pipeline device performed as intended, as indicated by successful implantation in the treatment of a paraclinoid right internal carotid artery (ica) aneurysm. The pipeline device remains implanted in the patient; product analysis cannot be performed. Ccf is a known inherent risk of pipeline implantation and is documented in the pipeline instructions for use (ifu. ) the authors hypothesize that a pathophysiological change at the interface between the cavernous ica and aneurysm neck ultimately caused the ccf. Gascou et al. (2014) proposed that the flow diversion stent redirects most of the blood flow into the parent artery which causes an increase in blood flow in the parent artery after ped placement. The cause of the ccf cannot be reliably determined; however, per the reported information, review of ifu, and review of literature to investigate the event, the most likely cause for the complaint is hemodynamic changes in which an increase in blood flow was observed in the parent artery after ped placement to treat large or giant aneurysm.
Event Description
Medtronic literature review found a report of carotid-cavernous fistula (ccf) after pipeline placement. The patient underwent pipeline implantation to treat a 12x12mm paraclinoid right internal carotid artery (ica) aneurysm with a 7mm neck that extended proximally to involve the cavernous segment. The article states that the pipeline (4. 5x18mm) was implanted without excess manipulation or complication. The distal end of the device was implanted in the paraophthalmic segment extending across the aneurysm neck with the proximal end in the cavernous ica. Immediate post-pipeline digital subtraction angiography (dsa) showed adequate apposition of the device to the parent vessel, contrast stasis within the aneurysm, and no evidence of vessel injury, extravasation, or early venous filling. After approximately 10 minutes, a repeat dsa showed early opacification of the right cavernous sinus, inferior petrosal sinus and superior ophthalmic vein, consistent with the development of a direct ccf. The decision was made to proceed with further flow diversion in attempts to exclude the fistulous site. Four additional pipeline devices were telescoped within the paraclinoid right ica across the aneurysm neck and extended proximally without the cavernous ica, resulting in decreased flow through the ccf. The patient was extubated and on post-interventional exam, the patient was stable. The following day, repeat angiography showed markedly decreased filling of the ccf. The patient did not undergo any further surgical intervention. The patient was discharged four days post-procedure on dual antiplatelet therapy (aspirin and ticagrelor. ) at both the two- and 12-month follow-up, the patient was asymptomatic with stable ophthalmologic exam, stable left visual acuity, and no clinical evidence of ccf. The 12-month follow-up angiogram showed progressive stasis of intra-aneurysmal flow with complete resolution of ccf. Amuluru, k. , al-mufti, f. , gandhi, c. D. , prestigiacomo, c. J. , <(>&<)> singh, i. P. (2016). Direct carotid-cavernous fistula: a complication of, and treatment with, flow diversion. Interventional neuroradiology, 22(5), 569-576. Doi:10. 1177/1591019916653255.
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Manufacturer (Section D)
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
MDR Report Key6451903
MDR Text Key106093695
Report Number2029214-2017-00344
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,Followup
Report Date 03/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFA-77450-18
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 Received03/08/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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: 04/02/2017 Patient Sequence Number: 1