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

Device Problem Activation, Positioning or SeparationProblem (2906)

Patient Problems Nerve Damage (1979); Therapeutic Response, Decreased (2271)

Event Date 03/28/2020

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

Ahmed, s. , hosseini, m. , santini, r. , sahajwani, s. , vallabhaneni, r. , toursavadkohi, s. , karwowski, j. , and nagarsheth, k. (2020) transcarotid endovascular repair of extracranial internal carotid artery aneurysms using flow reversal for distal embolic protection. Elsevier inc. Ann vasc surg. 67: 568. E13¿568. E18 doi. Org/10. 1016/j. Avsg. 2020. 03. 020. Medtronic literature review found reported of patient complications in association with the pipeline flex. The purpose of this article was to review 3 cases of distal extracranial internal carotid artery (ica) aneurysms treated with place ment of stent grafts by way of transcarotid approach and flow reversal for distal embolic protection. Only one patient was treated with a pipeline stent and the patient was an 83 year old male. The following intra- or post-procedural outcomes were noted: it was determined the first attempt at treatment was unsuccessful 6 months prior due to the significant tortuosity of the vessels, and the lack of trackability of the two pipeline devices from a transfemoral approach. Additionally, the pipeline stents were undersized for the vessel diameter in the case. The patient developed a hoarseness due to a left recurrent laryngeal nerve palsy from the aneurysm pulsation against the nerve. A computed tomography (ct) was performed which found incomplete exclusion of the previously treated aneurysm. The aneurysm was treated with other manufacturer's products, and post-procedure angiography demonstrated complete exclusion of the aneurysm and excellent flow into the distal ica. Patient was discharged on postoperative day 1 on dual antiplatelet therapy. The patient's hoarseness improved after the endovascular repair, and there were no other neurological symptoms. See attached literature article.

• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10624787
• MDR Text Key: 209771004
• Report Number: 2029214-2020-00995
• 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

• Type of Report: Initial
• Report Date: 10/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• 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 Received: 09/17/2020
• 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: 10/04/2020 Patient Sequence Number: 1