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

Model Number UNK-NV-PED2

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

Patient Problems Hematoma (1884); Intracranial Hemorrhage (1891); Vascular Dissection (3160)

Event Date 11/07/2017

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Kirill orlov, dmitry kislitsin, nikolay strelnikov, vadim berestov, anton gorbatykh, timur shayakhmetov, pavel seleznev, and anton tasenko; interventional neuroradiology; 2018; 24(3) 270¿273; experience using pipeline embolization device with shield technology in a patient lacking a full postoperative dual antiplatelet therapy regimen; doi: 10.1177/1591019917753824 journals.Sagepub.Com/home/ine.Medtronic received information in a literature article that a patient had complications with a second generation pipeline sent with shield technology device. a (b)(6) male presented with two aneurysms: one left middle cerebral artery (mca) large saccular aneurysm and one partially thr ombosed giant anterior communicating artery (acomm).Initial loading dose of antiplatelet medications (600 mg of clopidogrel and 300 mg of aspirin) followed by a daily dose of 75 mg of each medication. during the first stage of treatment, the subject underwent uneventful stent-assisted coiling of the mca aneurysm.  during the scheduled ped shield implantation, intraoperative perforation of the a2 segment of the anterior communicating artery wall occurred. extravasation was halted by temporary balloon occlusion followed by telescopic implantation of a second ped shield. immediate postoperative computed tomography (ct) showed signs of subarachnoid hemorrhage with formation of interhemispheric hematoma and ventricular breakthrough. the patient remained stable for the following 10 days at a glasgow coma scale (gcs) value of six. on day 11, he was switched from nasogastric tube (ngt) feeding to partial extra-parenteral feeding because of the appearance of malabsorption signs, possibly due to delayed gastric emptying.Aggregometry on day 12 revealed recovery of aggregometry parameters up to baseline levels (epinephrine-agonized aggregation: 79%; adp-agonized aggregation: 65%).

Manufacturer Narrative

Report pertains to a previous report with rr #: (b)(4).B5.Updated with additional information received.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported the article focus was referencing the beneficial effects of the pipeline shield and did not, in any way, concern any possible side effects or device malfunction.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13483717
• MDR Text Key: 286993684
• Report Number: 2029214-2022-00174
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-PED2
• Device Catalogue Number: UNK-NV-PED2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2022
• 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: 65 YR
• Patient Sex: Male