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

Model Number UNK-NV-MARATHON

Device Problem Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/01/2008

Event Type  Injury  

Manufacturer Narrative

B3: date is approximate.Month and year are confirmed valid.Concomitant medical products: product id unk-nv-onyx.G2: citation: authors: walcott b, gerrard j, nogueira r, nahed b, terry a, ogilvy c.Microsurgical retrieval of an endovascular microcatheter trapped during onyx embolization of a cerebral arteriovenous malformation.J neurointervent surg 3:77e79 2011.10.1136/j nis.2010.002733.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.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

Cerebral arteriovenous malformations (avms) are vascular lesions that are amenable to various treatment modalities including stereotactic radiosurgery, fractionated radiotherapy, endovascular embolization, microsurgical obliteration or combined modality treatment.A potential complication of endovascular therapy with embolization material is microcatheter entrapment.We report on a patient for whom surgery was combined with endovascular embolization to obliterate an avm and retrieve an entrapped endovascular microcatheter.A 52-year-old woman suffered a left parietal hemorrhage from an avm.She underwent staged endovascular embolization of the lesion using onyx material.During the second stage of the embolization, the microcatheter was retained in the onyx plug.It was decided to section the microcatheter at the groin and proceed with microsurgical obliteration of the avm, with removal of the entrapped microcatheter remnant.The avm was dissected circumferentially allowing the meticulous obliteration of the feeding vessels.A single remaining feeding vessel originating from the distal anterior cerebral artery was identified and suspected to contain the entrapped microcatheter.The location was confirmed using stereotactic guidance and the vessel was then sectioned allowing complete removal of the avm.The microcatheter (102 cm) was then extracted cranially using gentle traction.This demonstrates the first incidence of microcatheter removal after procedural entrapment in onyx embolization material.

• Brand Name: MARATHON
• 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: 17641796
• MDR Text Key: 322168196
• Report Number: 2029214-2023-01513
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-NV-MARATHON
• Device Catalogue Number: UNK-NV-MARATHON
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2023
• 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 H10...
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female