MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER UNK GUIDE CATHETER; CATHETER, PERCUTANEOUS

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 12/16/2022

Event Type  malfunction  

Manufacturer Narrative

Hidemasa saito, fumie sugihara, tatsuo ueda, hiromitsu hayashi, sayaka shirai, taiga matsumoto, ryutaro fujitsuna, shin-ichiro kumita, 'efficacy of endovascular treatment for completely occlusive acute¿subacute portal and mesenteric vein thrombosis with severe com plications in patients without cirrhosis', japanese journal of radiology, no.41(5), 2023.Doi: 10.1007/s11604-022-01377-9.Pmid:36680703.Pages: 541-550.A2: average age a3: majority gender b3: date of publication patient deaths were also included in the results of the journal article, however no causal link suggesting that the medtronic devices used in the patient cohort may have caused or contributed to the deaths was provided.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

A journal article was submitted for review titled "efficacy of endovascular treatment for completely occlusive acute¿subacute portal and mesenteric vein thrombosis with severe complications in patients without cirrhosis".The aim of this article was to evaluate the outcome of endovascular treatments (evts) for completely occlusive acute¿subacute portal and mesenteric vein thrombosis (pvmvt) with severe complications in patients without cirrhosis.A total of 19 patients with completely occlusive acute¿subacute pvmvt, who underwent evts, were enrolled in this study and were retrospectively assessed.All patients with symptomatic pvmvt were treated with systemic anticoagulation therapy initially.Evts were performed via one of the following two access routes: the percutaneous transhepatic approach or trans-ileocolic approach.The percutaneous transhepatic approach was the first choice; however, the trans-ileocolic approach was selected when bowel resection was necessary, and it was difficult to puncture the intrahepatic portal vein (pv) due to complete obstruction of both right and left hepatic pv.The endovascular method used in this study comprised a combination of the temporary evt session and the continuous catheter-directed thrombolysis (cdt).The endpoint of the combination therapy was recanalization of the intrahepatic pv of at least one lobe of the liver, main tract of the pv, and main tract of the superior mesenteric vein (smv).During the temporary evt session an 8f non-medtronic (mdt) sheath was inserted into the portal venous system via the transhepatic or trans-ileocolic route and heparin was administered to maintain the activated clotting time within the range of 200¿300 seconds.A 6f non-mdt catheter and an 8f mdt launcher guiding catheter were used for manual aspiration thrombectomy (at).A one-shot injection of the thrombolytic agent was administered using urokinase via a 5f non-mdt multiple-side-hole infusion catheter.Plain old balloon angioplasty (poba) was performed for fragmentation of the thrombus and crimping the thrombus to the vessel wall.Non-mdt bare metal stents were used in cases with mechanical stenosis or thrombi refractory to at, poba, and cdt.Most cases were initiated with at to remove the thrombus as much as possible.Cdt and poba were performed for residual thrombi refractory to at.Primary stenting was performed in cases of mechanical stenosis and thrombus confined to the main trunk of the pv and smv.The continuous cdt session was initialized when recanalization of pv and smv was not achieved.During the interval between each temporary evt session, an 8f non-mdt sheath and 5f non-mdt heparin-coated catheter remained in place within the smv and pv.Continuous cdt using urokinase was performed via the sheath and catheter for 24¿48 hours until the next temporary evt session.Continuous cdt via the ileocolic vein was managed using an open abdomen approach with vacuum-assisted wound closure (vac) in the intensive care unit.This open abdomen approach was limited to a maximum of 7 days.Eight patients did not undergo continuous cdt, as recanalization was achieved with one temporary evt session.Five of the eight patients who presented with bowel ischemia symptoms required bowel resection due to bowel necrosis prior to evts.None of the patients received transplants after evts.The primary outcomes of the study were all-cause mortality and acute¿subacute pvmvt-related mortality throughout follow-up.The secondary outcomes were the degree of recanalization immediately after evts, patency of pv on follow-up contrast-enhanced computed tomography (cect) or sonography, complications, factors related to acute¿subacute pvmvt-related mortality, and factors related to patency of pv.Seven patients died on days 10, 21, 32, 68, 78, 106 and 267 post-evts.Deaths were caused by multiple organ failure in five patients, hemoperitoneum in one patient, and lung carcinoma in one patient.All-cause and acute¿subacute pvmvt-related mortality rates were 36.8% (7/19) and 31.6% (6/19), respectively.Death due to hemoperitoneum occurred 32 days after evts, without thrombolysis and anticoagulation being performed.Hemoperitoneum was caused by disseminated intravascular coagulation related to pvmvt and had no direct relationship with evts.The five cases of death due to multiple organ failure were in hospital deaths, and multiple organ failure was considered related to pvmvt.Seven patients recovered clinically and survived for > 3 years after the intervention.Overall, 11 patients achieved complete recanalization and 7 achieved partial recanalization.Only one patient with an amoebic liver abscess exhibited no recanalization.Seven patients developed complications, with all of them being related to bleeding and included subcapsular hematoma, intrahepatic hematoma, hemoperitoneum, intrahepatic hematoma, intrahepatic hemorrhage and lumbar arterial hemorrhage.The bleeding required various interventions: conservative hemostasis in three patients, transfusion in two patients, trans-arterial embolization of the hepatic artery in one patient, and trans-arterial embolization of the lumbar artery in one patient.

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: LAUNCHER UNK GUIDE CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18362767
• MDR Text Key: 331338685
• Report Number: 1220452-2023-00108
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2024
• 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 Age: 60 YR
• Patient Sex: Female