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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Infarction, Cerebral (1771); Occlusion (1984); Thrombosis (2100); Transient Ischemic Attack (2109); Vasoconstriction (2126)

Event Date 01/05/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.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.The reported adverse events are known inherent risk of endovascular procedure and are documented in our device¿s instruction for use (ifu).Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure and patient condition related events.If information is provided in the future, a supplemental report will be issued.

Event Description

Matthew t bender, bowen jiang, jessica k campos, li-mei lin, narlin beaty, chau d vo, david a zarrin, justin m caplan, judy huang, rafael j tamargo, geoffrey p colby, alexander l coon.Bender mt, et al.J neurointervent surg 2018;10:843¿850.Doi:10.1136/neurintsurg-2017-013739.Medtronic received the following reports through literature review of ¿single-stage flow diversion with adjunctive coiling for cerebral aneurysm: outcomes and technical considerations in 72 cases¿ a total of 72 pipeline with adjunctive coiling (pac) procedures were performed on 69 patients.The population was 86% female with average age of 58 years.There were progressive increases in fluoroscopy time and radiation exposure with added procedural complexity, which were not statistically significant.Adverse events: 12 cases of vasospasms that were treated with verapamil.Pipeline thrombosis occurred in 9 cases.3 major stroke complications occurred.8 minor complications occurred.There was one case of death.2 tia events occurred.1 asymptomatic dissection event occurred.Malfunctions: balloon angioplasty was performed in 21 cases.There was one case where the pipeline was corked and removed.Balloon angioplasty was used in 29% of pac cases and platelet aggregation along the stent requiring treatment with intra-arterial ab ciximab was seen in 13%.Procedural success was achieved in 70/72 cases (97%).Both failures were initially attempted as sequential pac and were converted to successful single-modality flow diversion (cases 36 and 50).The three major complications were strokes.Minor neurological complications were observed in two cases, both transient ischemic att acks; minor non-neurological complications were observed in six cases (7%), including five groin hematomas and one asymptomatic dissection.The major complications encountered were as follows: case 12 had left anterior cerebral artery (aca) to internal carotid artery (ica) ped placed with additional coiling via the bifemoral technique for a 9 mm proximal left a1 aneurysm with a 5.8 mm neck.The patient experienced left middle cerebral artery (mca) stroke on pod1 secondary to hypotension from a large retroperitoneal hematoma and ultimately died from the stroke.Case 53 underwent pac via the single-intermediate technique of a 13 mm right mca bifurcation aneurysm with 8 mm neck.At the end of the procedure mild platelet accumulation was observed within the ped and 5 mg intra-arterial abciximab was administered with normal anterograde filling of the right mca throughout.The patient awoke with left-sided hemiparesis, mri showed right basal ganglia infarct, and the patient had a modified rankin scale (mrs) score of 4 at last follow-up.Case 56 had pac via the bifemoral approach of a 9 mm right a2¿a3 junction aneurysm with a 5.4 mm neck.Dsa following stent and coil deployment showed occlusion of the covered callosomarginal branch.The vessel opened with escalating doses up to 20 mg abciximab.The patient awoke with left lower extremity weakness and had punctate infarcts in the right aca distribution on mri but had an mrs score of 1 at last follow-up.Septagenarian female who presented with facial pain from a giant 28 mm right internal carotid artery ophthalmic segment aneurysm with a 9 mm neck.(a) unsubtracted lateral neck digital subtraction angiogram (dsa) demonstrating triaxial set-up for deployment of the pipeline embolization device (ped) with 5f envoy brought up through the contralateral femoral artery for coiling.Lateral view 3d rotational angiogram.Lateral dsa crossing the aneurysm with 0.0165-inch catheter, pre- and post-loop reduction.Lateral dsa mid-deployment, wagging to promote opening results in intermediate catheter tracking back to petrocavernous junction.Lateral dsa ped deployment into the intermediate catheter to eliminate a twist in the device.Lateral dsa aneurysm coiling following balloon angioplasty to promote apposition of the proximal device.Six-month follow-up dsa showing complete aneurysm occlusion.Case 26, a woman in her mid-70s with 28 mm true ophthalmic aneurysm, an independent intermediate catheter plays an essential role in the manipulations required to deploy a ped across the neck of a giant aneurysm.A jailed technique was selected to prevent coil herniation into the parent vessel, given the 9 mm neck of this aneurysm.This aneurysm was initially crossed with an omegalooped 0.0165-inch microcatheter that was then reduced before being exchanged for the 0.027-inch microcatheter for ped deployment.The bifemoral technique is always used when loop reduction is anticipated because it increases the risk of ped twisting during deployment.Significant wagging was required to open the device along the supraclinoid ica, which resulted in the intermediate catheter tracking back to the petrocaverous junction, a manipulation that could not be done with a parallel coiling catheter in place.The proximal ped was then deployed partially into the intermediate catheter to progressively reduce an observed twist in the device.Finally, the 0.027-inch microcatheter was removed and balloon angioplasty was performed at regions of malapposition along the horizontal cavernous ica, all before attention was turned to the relatively straightforward aneurysm coiling.

• Brand Name: PIPELINE
• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9208661
• MDR Text Key: 173042450
• Report Number: 2029214-2019-01033
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention