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

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

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Ischemia (1942); Renal Failure (2041); Obstruction/Occlusion (2422); Vascular Dissection (3160); Embolism/Embolus (4438)

Event Date 04/02/2021

Event Type  Injury  

Manufacturer Narrative

Journal article: a comparison of outcomes based on vessel type (native artery vs.Bypass graft) and artery location (below-knee artery vs.Non-below-knee artery) using a combination of multiple endovascular techniques for acute lower limb ischemia authors: tatsuo ueda, hiroyuki tajima, satoru murata, et.Al.Journal: annals of vascular surgery year: 2021 reference: doi.Org/10.1016/j.Avsg.2021.02.023 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 death(s) was provided: average age, sex: majority gender, date of event: date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article titled - a comparison of outcomes based on vessel type (native artery vs.Bypass graft) and artery location (below-knee artery vs.Non-below-knee artery) using a combination of multiple endovascular techniques for acute lower limb ischemia - was submitted for review.To aim of this study was to evaluate outcomes of endovascular treatment (evt) using a single or combination of multiple endovascular techniques for acute lower limb ischemia (alli), and to compare outcomes based on vessel type and artery location.Vessel type was classified into native artery occlusion and bypass graft occlusion.Based on the location of the occluded artery, native arteries were categorized into below-knee occlusion and non-below-knee occlusion.Types of evts included catheter-directed thrombolysis (cdt), percutaneous aspiration thrombectomy (pat), balloon angioplasty, and stent implantation.Additional evts were performed for residual thrombosis, following the initial evt.Thromboembolectomy was performed for massive thrombus in large vessels.Medtronic launcher guide catheter was among the devices used in the pat procedures.Technical success, perioperative death (pod), alli-related death, amputation, amputation-free survival (afs), and complications were compared according to vessel type and artery location.A total of 95 patients with alli who received either single or multiple evt, with or without surgical thromboembolectomy, were included in the study.Single evt techniques were performed in 16 patients, while a total of 61 patients had the pat procedure.The technical success and pod rates were 94.7% and 11.6%, respectively, in the total number of patients.A total of 11 patients died, four of whom died of alli, whereas seven died due to other causes (sepsis, 3; cancer, 1; superior mesenteric artery occlusion, 1; unknown, 2).Amputation occurred in six patients, all belonging to the below-knee occlusion group.Ischemia/reperfusion injury was noted in 3 patients.Compartment syndrome and major bleeding occurred in 3 and 5 patients respectively.Dissection was observed in 4 patients.One patient showed brain and kidney infarctions.Distal embolization occurred in 13 patients.

• Brand Name: LAUNCHER
• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12873810
• MDR Text Key: 285991531
• Report Number: 1220452-2021-00075
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K132673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2021
• 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: 72 YR
• Patient Sex: Male