MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CONCERTO PGLA HLX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number PV-16-40-HELIX

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problem Myocardial Infarction (1969)

Event Date 03/08/2023

Event Type  Death  

Event Description

Zacà s, patruno i, pulli r, angiletta d.Endovascular repair using parallel grafts to treat a suprarenal pancreatitis-related abdominal aortic pseudoaneurysm.Catheterization and cardiovascular interventions¿: official journal of the society for cardiac angiography interventions.2023;101(5):888-891.Doi:10.1002/ccd.30624.Medtronic literature review found a report of myocardial infarction/death in association with concerto coils.The purpose of this article was to report an impending rupture of a chronic pancreatitis-related suprarenal abdominal aortic pseudoaneurysm successfully treated with the chimney and the periscope graft technique.In addition, this case highlights the crucial role of an accurate preoperative plan and the importance of bail-out endovascular techniques to obtain technical success.A 74-year-old female patient was admitted to a geriatric division of a peripheral center with acute hemorrhagic necrotic pancreatitis.A computed tomography (ct) scan showed a normal aorta and the patient underwent medical treatment and was discharged after 10 days.Three months later, the patient was newly hospitalized suffering abdominal pain and progressive anemization requiring hemotransfusions.A new contrast-enhanced ct scan revealed a large-neck aortic pseudoaneurysm located between the celiac artery (ca) and the origin of the superior mesenteric artery (sma) and associated with a fluid peri-aortic collection.  an aortouniliac (aui) stent-graft was planned as an aortic main body combined with two chimney stents for ca and sma and two periscope stents for renal arteries.Pseudoaneurysmal sac coil embolization was considered through a catheter left into the sac at the end of the procedure.  two self-expanding covered stents (viabahn) 5 × 100 mm were placed in each renal artery.Two balloon-expanding covered stents (e-ventus bx) 10 × 57 and 7 × 57 mm were respectively placed into the ca and sma.An aortic stent-graft (aui endurant ii etuf 2814102) was placed just above the origin of ca through the right femoral access.The aortic stent-graft was intended to oversize 20%¿30 proximally and 10%¿15% distally.The procedure was complicated by the entrapment of the left brachial sheath into the barbs of the aui stent-graft and, moreover, the balloon catheter of the ca chimney stent was joined with the sheath making difficult its withdrawal.Bail-out endovascular strategy was attempted to solve this issue.It was decided to snare and pull down the free flow of the aui stent-graft and at the same time an opposite force from above to remove the sheath from the left brachial access was applied.During this procedure, a 2 cm upward migration of the aui stent-graft was observed with the displacement of the two renal stents.The sheath and the balloon were retrieved from the left brachial access and their integrity was immediately assessed.Subsequently,  the aui stent-graft was extended with a tapered stent-graft distally (gore excluder pll 161407) and the renal arteries were relined using two self-expandable covered stents and fixed with two bare-metal stents (smartflex stent) at the distal landing zone.The sma stent was re-engaged through left brachial access and extended proximally with a balloon-expandable 8 × 57 mm stent to match the proximal edge of the displaced aui stent-graft.After numerous attempts to re-engage the ca stent, the target vessel was killed leaving the stent between the aui graft and the aortic wall.At the end of the procedure, the pseudoaneurysmal sac was embolized with coils (helix ev3 concerto) delivered using a catheter previously left within the sac.Completion angiography showed complete exclusion of the aortic pseudoaneurysm with retrograde perfusion of the ca by the sma and the patency of the renal arteries.No gutter/endoleaks were observed at the end of the procedure.The patient was admitted to intensive postoperative intensive care unit for 24 h and then transferred to the ward.The postoperative period was uneventful and the in-hospital length of stay was 7 days.At 6 months follow-up the patient was healthy, and the ct scan confirmed the exclusion of the aortic lesion and the patency of all the stent-grafts.No endoleak/gutters were observed and the asymptomatic occlusion of the ca stent was confirmed.Unfortunately, the patient died after 10 months from the intervention as a result of myocardial infarction the article does not state any technical issues during use of the concerto coils the following intra- or post-procedural outcomes were noted: patient died after 10 months from the intervention as a result of myocardial infarction.

Manufacturer Narrative

G2: citation: authors: zacà, s., patruno, i., pulli, r., angiletta, d.Endovascular repair using parallel grafts to treat a suprarenal pancreatitis-related abdominal aortic pseudoaneurysm.Catheterization and cardiovascular interventions: official 5 2023.Doi:10.1002/ccd.30624 earliest date of publication used for date of event no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.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.

Manufacturer Narrative

B5.Updated with additional information received from article communicating author.As there was no reported malfunction and the adverse event is not associated with the medtronic device(s), this event is no longer a reportable event.Mdr decision corrected to not reportable.No additional supplemental mdrs are required unless additional information received makes the event reportable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information received from the communicating author reported the patient's death was not associated with the concerto coils.Implanted concerto coils: included helix ev3 concerto pv 1640 lot a366207; helix ev3 concerto pv 1640 lot a357326; helix ev3 concerto pv 1640 lot a364247; helix ev3 concerto pv 1640 lot a364247; helix ev3 concerto pv 1430 lot a366201; helix ev3 concerto pv 1430 lot a374709; helix ev3 concerto pv 1430 lot a 378790; helix ev3 concerto pv 1640 lot a 366207 as there was no reported malfunction and the adverse event is not associated with the medtronic device(s), this event is no longer a reportable event.Mdr decision corrected to not reportable.No additional supplemental mdrs are required unless additional information received makes the event reportable.

• Brand Name: CONCERTO PGLA HLX
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• 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: 18322614
• MDR Text Key: 330427879
• Report Number: 2029214-2023-02369
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536017078
• UDI-Public: 00847536017078
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K090046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2019
• Device Model Number: PV-16-40-HELIX
• Device Catalogue Number: PV-16-40-HELIX
• Device Lot Number: A366207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• Date Device Manufactured: 10/26/2016
• 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): Death
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 90 KG