MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-325-12

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Pain (1994)

Event Date 05/18/2020

Event Type  Injury  

Manufacturer Narrative

Please note that this date is based off of the date of publication of the article [or the date that the article was accepted for publication] as the event dates were not provided in the published literature.If information is provided in the future, a supplemental report will be issued.

Event Description

Amey r.Savardekar, devi prasad patra, anil nanda & hugo humberto cuellar-saenz (2020) retrograde trans-posterior communicating artery rescue balloon angioplasty of incompletely expanded pipeline embolization device: complication management, british journal of neurosurgery, doi: 10.1080/02688697.2020.1764495 medtronic literature review found reported of one pipeline complication in association with treatment of an intracranial aneurysm.A (b)(6)-year african-american female presented with long-term history of headaches.Work-up revealed a saccular aneurysm measuring 9.9 x 7mm with a 3.6mm neck arising from the intracranial (v4) segment of the dominant left vertebral artery (va).Intravenous heparin was given to achieve anti-coagulation.A 6fr envoy catheter, excelsior sl-10 microcatheter, and 0.014 synchro guidewire were used to gain access to the aneurysm.An 8mm x 30 cm 3d axium coil and a second coil were placed into the aneurysm.A marksman microcatheter was then delivered and positioned in the basilar artery.The pipeline (ped) was advanced and deployed within the v4 segment of the left va.The proximal section opened partially and was not opposed to the vessel wall.Several attempts to traverse the ped with the marksman were unsuccessful.An sl-10 microcatheter was advanced in an attempt to open the stent, but it was unsuccessful.During the manipulation, the distended stent migrated distal to the neck of the aneurysm.Two more coils were placed in the aneurysmal neck to obtain complete occlusion.A dsa run showed flow through the dominant left va was restricted due to the partially unexpanded ped.The patient complained of severe neck pain during the manipulations and was placed under general anesthesia.A balloon was then delivered inside the ped and angioplasty was performed to widen the narrowed segment of the stent.A dsa run showed complete patency of the left va and complete occlusion of the aneurysm with no flow restriction to the basilar artery.It was noted the posterior circulation was severely tortuous.Post-operatively, the patient did well and did not have any neurological deficits.Follow-up dsa at 1 year showed regrowth of the aneurysmal neck, which required a follow-up procedure of coiling for obliteration of the recurrent aneurysm.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10916787
• MDR Text Key: 218695182
• Report Number: 2029214-2020-01204
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• 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: 11/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED-325-12
• Device Catalogue Number: PED-325-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2020
• 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): Required Intervention
• Patient Age: 71 YR