MAUDE Adverse Event Report: COVIDIEN PROTEGE RX CAROTID STENT SYSTEM; STENT, CAROTID

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

Patient Problem Vascular Dissection (3160)

Event Date 05/01/2020

Event Type  Injury  

Manufacturer Narrative

Journal title: endovascular aortic repairs combines with looping-chimney technique for repairing aortic arch lesions and reconstructing left common carotid artery journal: journal of thoracic disease year: 2020 ref: doi: 10.21037/jtd.2020.0.Date of publication note: journal reported death but there is no information to suggest the device caused or contributed to the death events.Deaths are common occurrences in clinical studies, however the cause(s) of death are often not characterized or clearly associated with a particular product.Therefore, deaths will not be considered reportable unless clearly stated as being associated with a medtronic device.If information is provided in the future, a supplemental report will be issued.

Event Description

The aim of this retrospective study was to evaluate the feasibility and efficacy of thoracic endovascular aortic repairs (tevar) combined with looping chimney technique (lct) for repairing aortic arch lesions and reconstructing left common carotid artery.Total of 14 patients were included in the study from december 2016 to december 2018.Aortic arch pathologies of all patients with insufficient proximal landing zone (plz) were repaired by tevar under local anesthesia, before tevar, the left common carotid artery (lcca) was protected by the guiding sheath from the retrograde brachial access, after aortic stent graft deployed, chimney graft was implanted to restore lcca by lct if necessary.All patients underwent computed tomography angiograph (cta) 2 weeks, 3 months, 6 months and 1 year after surgery.Pathology results of 14 patients included: type b aortic dissection (n=8), penetrating aortic ulcers (n=1), retrograde type a aortic dissection (n=1), thoracic aortic aneurysm (taa) (n=2), and thoracic aortic pseudoaneurysm (n=2).In all patients, aortic arch lesions were repaired by tevar; while lcca were successfully reconstructed by the lct.In one case, the innominate artery (ia) was simultaneously reconstructed through the same percutaneous right brachial artery (rba) access.Coiling eliminated type ia endoleak in 3 patients, and type ii endoleak vanished by plugging left subclavian artery (lsa) in 2 patients.In four patients, the chimney stent (cg) of lcca was partially compressed and then another bare stent was implanted to restore patency rate.The mean follow-up duration was 9.77±6.64 months (range, 0¿24) and no combinations were observed in 13 patients; except in one patient who died of cerebral hemorrhage due to abnormal coagulation function.Conclusions: tevar combined with lct has shown to be suitable surgical approach for aortic arch lesions.Either covered intentionally or inadvertently, the lcca could be safely and effectively reconstructed via percutaneous rba access.Short-term follow-up demonstrated satisfactory morbidity and mortality in high-risk patients; however, longer follow-up is required to assess the effectiveness and durability of this innovative endovascular procedure.The literature presented the demographics, comobidities and adverse events of all 14 patients in the population study.Complete se and protege gps stents were implanted during procedure.There are 3 patients out of the 14 with serious illness injury of thrombus and dissection, and one patient death.But the death is not reported to be related to the device.All patients with serious illness injury and death all had protege gps stents implanted.There are no device related serious illness injury reported against the complete se.

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.

• Brand Name: PROTEGE RX CAROTID STENT SYSTEM
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10312113
• MDR Text Key: 205879120
• Report Number: 2183870-2020-00226
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/14/2020

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 09/11/2020
• Supplement Dates FDA Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 46 YR