MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 HYPERFORM; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number 104-4470

Device Problem Burst Container or Vessel (1074)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2023

Event Type  malfunction  

Event Description

Medtronic received a report that the right middle carotid artery was accessed and the pipeline was delivered with the phenom microcatheter.Once loaded, it was accurately placed and deployment was started.The distal portion wasn't opening at the tortuous bend.After 5-6 attempts of resheathing, it was decided to resheath again and introduce the device again.But while the final resheathing was taking place into the microcatheter, the device opened inside the phenom.The pipeline was deployed less than 50% when it failed to open.There was catheter resistance at the distal end of the catheter.The hyperform 4x7 was taken which while preparing tore because the wire went through the balloon.So a second re-sterilized balloon was taken.The pipeline and the microcatheter were resheathed and removed from the patient.The pipeline and any accessories were prepared as indicated in the instructions for use (ifu).The catheter was flushed as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of a saccular, unruptured right ica aneurysm with a max diameter of 15mm and a 8mm neck diameter.The landing zone had a measurement of 4.2mm proximally and 3.9mm distally.The access vessel was the right common carotid to internal carotid artery with a diameter of 4.2mm.It was noted the patient's vessel tortuosity was severe.

Manufacturer Narrative

Refer to manufacturer's report 2029214-2023-01532 for details pertaining to the reportable related event.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.

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 was received that there was no damage observed to the pipeline pushwire.The pipeline had not been placed in a vessel bend when it failed to open, it was in a straight segment.The guidewire tip was advance about 10mm out of the catheter tip during the inflation.The balloon leak was at the tip.The contrast ratio was 50:50.The physician did not shape the guidewire tip.The injection rate was steady.A 1ml luer lock syringe was used.

Manufacturer Narrative

H3: product analysis #705742624:¿equipment used: video inspection system (m-78210), ruler 200cm (m-83361) ¿drawing(s) referenced: dwgs104-4770 rev.Bd ¿ as found condition: the hyperform occlusion balloon catheter was returned for analysis within a shipping box; within an opened hyperform occlusion balloon catheter outer carton and inner pouch; and within a dispenser coil.¿ damage location details: no damages or irregularities were found with the balloon catheter hub.No bends or kinks were found with the hyperform catheter body.No damages or irregularities were found with the balloon.No damages were found with the hyperform balloon/distal tip.No other anomalies were observed.¿ testing/analysis: the total and usable lengths of balloon catheter were measured to be within specifications.The hyperform occlusion balloon catheter was flushed, blood and water exited from the distal tip.An in-house x-pedion-10 guidewire was hydrated and inserted through the hyperform occlusion balloon catheter lumen.The balloon was inflated and held inflation.No leaks or ruptures were detected.¿ conclusion: based on the device analysis and reported information, the customer¿s report of ¿balloon rupture during set up¿ could not be confirmed.No leaks or ruptures were detected upon inflating the hyperform balloon.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: HYPERFORM
• Type of Device: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; case postale; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; case postale; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 17652559
• MDR Text Key: 322311050
• Report Number: 9614453-2023-03066
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K101570
• 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: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 104-4470
• Device Catalogue Number: 104-4470
• Device Lot Number: B289479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2021
• 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 Age: 57 YR
• Patient Sex: Female