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 Problem Thrombosis/Thrombus (4440)

Event Date 07/17/2023

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id unk-nv-cragg-mc (lot: unknown); product type: ; implant date n/a; explant date n/a g2: citation: authors: jenab, y., tofighi, s., ayati, a., rezvanimehr, a., moosavi, n., jalaie, h., <(>&<)> barbati, m.E.Single-center experience with catheter-directed thrombolysis and balloon angioplasty for acute upper-extremity deep vein thrombosis: a case series study.Bmc cardiovascular disorders 23(1) 2023.Doi:10.1186/s12872-023-03389-3 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

Jenab y, tofighi s, ayati a, et al.Single-center experience with catheter-directed thrombolysis and balloon angioplasty for acute u pper-extremity deep vein thrombosis: a case series study.Bmc cardiovascular disorders.2023;23(1).Doi:10.1186/s12872-023-03389-3 medtronic literature review found a report of patient complications in association with a cragg-mcnamara infusion catheter.The purpose of this article was to presents a review of experience with catheter-directed thrombolysis (cdt) followed by balloon venoplasty in patients with acute primary upper extremity deep vein thrombosis (uedvt).Twelve patients were included in this study, of whom eleven were male, and the mean age was 41.08 years.Cdt was performed with a perfusion catheter with continuous infusion of rt-pa (alteplase) at a rate of 1 mg/h for 24¿48 hours until the symptom improved.The article does not state any technical issues during use of the cragg-mcnamara infusion catheter.The following intra- or post-procedural outcomes were noted:  - one patient had recurrent symptoms in their target limb which required a decompression surgery.Despite the surgery, the patient¿s condition did not improve, and a repeated balloon venoplasty was performed, resulting in symptom resolution. - cdt led to unfavorable outcomes concerning residual stenosis before the balloon venoplasty, with only partial thrombus removal in 7 of the 12 patients.However, following balloon venoplasty, all patients exhibited significant stenosis improvements and complete thrombus removals. - two patients experienced a drop in blood pressure. - two patients experienced intermittent swelling with arm use.

• 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: 19140808
• MDR Text Key: 340566099
• Report Number: 2029214-2024-00701
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: IR
• 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: 04/18/2024

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
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2024
• 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
• Treatment: SEE H11...
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR