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

Model Number NV UNK PIPELINE

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Stroke/CVA (1770); Muscle Weakness (1967)

Event Date 02/12/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Valerio da ros, francesco diana, federico sabuzi, emanuele malatesta, antioco sanna, jacopo scaggiante, francesca di giuliano, roberto gandini, roberto floris, maria ruggiero.Flow diverters for ruptured posterior circulation perforator aneurysms: multicenter experience and literature review.Journal of neurointerventional surgery 12 (2020).Doi:10.1136/neurintsurg-2019-015558 the purpose of the study was to evaluate flow diverter stents' safety and efficacy at mid- to long-term follow-up.A diagnostic and therapeuticalgorithm for rpcpas (ruptured posterior circulation perforator aneurysms) is also proposed.In one case the patient was admitted to our emergency department with severe headache and nuchal rigidity for at least 5 days.A ct scan showed sah into the interpeduncular cistern (modified fisher grade 3); the subsequent dsa revealed a perforating aneurysm of the basilar artery (type iii).A ped fd (2.5×10mm) was immediately deployed during intravenous gp iib/iiia inhibitor infusion.No nimodipine infusion was used.Antiplatelet loading included tirofiban bolus and tirofiban which was a 12 hour infusion.Antiplatelet regime included asa 300mg and clopidogrel 75mg.The patient was discharged a few days later without neurological deficit.Fifteen days later the patient was admitted to the emergency department with left sided hyposthenia.Brain mri revealed a pontine paramedian infarction.A dsa showed enlargement of the basilar artery diameter, which was 1mm larger than during the treatment, as well as a shortened fd with poor wall apposition of the proximal end of the stent.Therapeutic abstention was preferred and a short-term follow-up was planned.

Manufacturer Narrative

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 that the problem was not related to the device itself but to the operators who underestimated the vessel dimension due to the vessel vasospasm.

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10972176
• MDR Text Key: 220424185
• Report Number: 2029214-2020-01254
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NV UNK PIPELINE
• Device Catalogue Number: NV UNK PIPELINE
• Device Lot Number: NOT-REP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other