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

Device Problem Migration (4003)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 09/03/2019

Event Type  Injury  

Manufacturer Narrative

The devices have not been returned; the reported events could not be confirmed.The causes of the events could not be conclusively determined from the reported information.If information is provided in the future, a supplemental report will be issued.

Event Description

Shields, l.B., shields, c.B., ghiassi, m., dashti, s.R., yao, t.L., zhang, y.P., & ghiassi, m.(2019).Pipeline embolization device for treatment of craniocervical internal carotid artery dissections: report of 3 cases.World neurosurgery, 132, 106¿112.Doi: 10.1016/j.Wneu.2019.08.183 medtronic literature review found a report of retreatment after pipeline (ped) implantation.A patient presented with pre-existing headache and ipsilateral partial horner's syndrome due to dissection of the distal left internal carotid artery.The patient underwent endovascular treatment in which four telescoping peds were implanted to reconstruct the left ica dissection from the petrous down to its origin in the cervical segment to create adequate flow diversion.Postoperatively, the patient had complete resolution of his headache and horner¿s syndrome and was discharged on aspirin and clopidogrel.Five months post-procedure, dsa demonstrated excellent revascularization; however, a separation of the 2 peds was identified at the skull base, along with evidence of a small residual pseudoaneurysm at the space between the peds.An additional ped (5 x 35 mm) overlapping the gap was placed, resulting in good flow diversion.At 4 months after the second procedure, repeat angiography revealed normal vessel caliber and flow with complete endothelialization of the peds.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• 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: melody roppel ; 1000 colonel anderson pkwy; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9919055
• MDR Text Key: 195547034
• Report Number: 2029214-2020-00324
• 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: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2020
• 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: 35 YR
• Patient Weight: 84