MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CRAGG-MCNAMARA; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-CRAGG-MC

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

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Rupture (2208); Stenosis (2263); Pseudoaneurysm (2605); Vascular Dissection (3160); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 05/03/2022

Event Type  Injury  

Manufacturer Narrative

G2: citation: authors: janjindamai, p., hongsakul, k., sungsiri, j., bannangkoon, k., & liabsuetrakul, t.The related factors to the re-thrombosis of hemodialysis arteriovenous graft after endovascular salvage.Seminars in dialysis 3 2023.Doi:10.1111/sdi.13091 a.2.This value is the median age of the patients reported in the article as specific patients could not be identified.A.3.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.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 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Janjindamai p, hongsakul k, sungsiri j, bannangkoon k, liabsuetrakul t.The related factors to the re-thrombosis of hemodialysis arteriovenous graft after endovascular salvage.Seminars in dialysis.2023;36(3):208-213.Doi:10.1111/sdi.13091 medtronic literature review found a report of patient complications in association with the cragg-mcnamara infusion catheter.The purpose of this article was to determine the related factors to the re-thrombosis of arteriovenous grafts (avgs) after endovascular treatment.All patients who underwent hemodialysis with thrombosed avg, who had pharmacomechanical thrombolysis from january 2016 to december 2018, were enrolled.A total of 157 patients with thrombosed hemodialysis avg were enrolled.This study included 70 (44.6%) males and 87 (55.4%) females.The median age of patients was 65 years; ranging from 24 to 94 years.Procedural success was defined as restoration of flow in the dialysis graft, with a palpable thrill and < 30% residual diameter of stenosis.Postintervention primary patency was defined as the time from the pharmacochemical thrombolytic procedure until the next dialysis graft thrombosis or reintervention.Complications were defined as major and minor types.Major complications were those that required additional treatment and result in permanent sequelae or death.Minor complications were problems requiring no or nominal therapy and no sequelae.The article does not state any technical issues during use of the medtronic device.The following intra- or post-procedural outcomes were noted: -4 cases of minor bleeding -4 cases of arterial emboli -6 ruptured draining vein which was mostly controlled by low-pressure balloon tamponade.However, one case was placed with a stent-graft due to failure from balloon tamponade.-1 case of dissection of the draining vein -5 cases of peri-graft hematoma -1 puncture site pseudoaneurysm -post-intervention primary patency rate at 1, 3, and 6 months were 79.0%, 67.1%, and 54.0%, respectively.- the most common cause of graft thrombosis includes venous anastomotic stenosis (98.7%), and 62 cases had thrombosis that extends to the draining vein.Multiple sites of underlying access stenosis were found (68.8%).The most common were two sites of access stenosis (38.2%).Pre-existing graft pseudoaneurysms were found in 13.4%.The procedure success rate was 86.0%, wherein 110 avgs succeeded with thrombolysis plus balloon angioplasty, whereas 25 avgs needed additional stenting at venous anastomosis due to residual elastic recoil stenosis of >30%.

• Brand Name: CRAGG-MCNAMARA
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: 19147858
• MDR Text Key: 340676652
• Report Number: 2029214-2024-00711
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-CRAGG-MC
• Device Catalogue Number: UNK-NV-CRAGG-MC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2024
• 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 Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female