MAUDE Adverse Event Report: COVIDIEN LLC REBAR; CATHETER, CONTINUOUS FLUSH

Model Number 105-5083-153

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

Patient Problems Ischemia Stroke (4418); Thrombosis/Thrombus (4440)

Event Date 12/10/2023

Event Type  Death  

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.

Event Description

Medtronic received a report that the stent could not be detached.No patient symptoms or further complications were reported as a result of this event.Ancillary devices include an unknown detachment box.Additional information was received that the product was supposed to open a stenosis in left m1 with a thrombus within and was placed correctly.The detachment box was placed as indicated and the physician was experienced.21g needle was used in the left upper leg and the detachment process was started.The catheter tip was 1-1,5 cm placed proximal the marker.After 2 minutes, the detachment box indicated the stent was released.The wire was pulled back, but the stent was still attached.Since the stenosis was open at that point, the physician used no second device.At this point it was a successful and good clinical result.It was noted that the physician heard that the patient suffered later on a stroke but had today no information or evidence, how the patient is doing.Additional information was received that the patient had basilar thrombosis, and after thrombectomy there was a stenosis in the treated territory.The physician wanted to place the solitaire ab in the affected vessel.The detachment was tried only once.The detachment area was around 1.5-2cm away from the microcatheter tip.After non-detachment, the physician decided to take the sab-4-20 out.It seemed to him that the stenosis looked a little bit more open compared to the picture right after the mechanical thrombectomy and they decided to leave it like this.The patient unfortunately got another stroke in the posterior circulation the next day and died short time later.Ancillary devices include a rebar18 microcatheter, neuron max6f, preset 4-20, traxcess 14ex, and sofia dac 5f.

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.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

Additional information received reported that the patient suffered a new basilar thrombosis after treatment and passed away in the hospital.The death was not thought to be related to the medtronic device or therapy.There had been no resistance while delivering the stent.The solitaire had been deployed for 5 minutes prior to detachment.The physician attempted to detach the stent with the detachment box for one circle.The detachment box displayed as indicated per the ifu, and the cable polarity was set up per the ifu.A 20g needle was used.There was no visible damage to the detachment cable.The needle was placed into the muscle of the groin.The black cable was connected to the needle, and the red cable was connected to the pusher wire, which was on a dry clean surface.The stent was positioned in the basilar artery and not in a bend.The detachment box had been re-used, and the detachment cable was new.The physician had used a new battery during detachment.The patient¿s vessel tortuosity was moderate.

Manufacturer Narrative

Section e) initial reporter information updated.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: REBAR
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 18566760
• MDR Text Key: 333515955
• Report Number: 9612501-2024-00209
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 105-5083-153
• Device Catalogue Number: 105-5083-153
• Device Lot Number: 0226369484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Date Device Manufactured: 04/22/2023
• 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
• Patient Outcome(s): Other; Death