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

Model Number 104-4715

Device Problem Burst Container or Vessel (1074)

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

Event Date 07/18/2022

Event Type  malfunction  

Event Description

Medtronic received information regarding a ruptured hyperform balloon. it was reported that the patient was being treated for a left internal carotid artery (ica) tumor and the hyperform balloon was being used in a balloon test occlusion.The hyperform balloon catheter was prepared per the instructions for use (ifu).The hyperform was then inserted through the sheath and guide catheter and inflated using a medtronic cadence syringe to 0.20cc (5.7mm balloon size).The balloon was noted to be losing pressure so the doctor removed it and noted contrast exiting the distal tip.There was no patient injury.

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.

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

Additional information received reported that the lesion characteristics (location, size, type, side, dimension,¿etc.) were left ica aneurysm near pcom aneurysm 4mm x 6mm neck 3.5 mm side wall off left ica.Vessel tortuosity was moderate.A hyperform balloon 7x15 was used to complete the case.Hyperform was prepped and inflated pre procedure without rupture noted.Hyperform inflated preprocedure without incidence.Xpedion guidewire was 3 mm distal to distal tip marker.The rupture was noted at midsection of the balloon.A 50/50 contrast was used to prep balloon.A slight curve was shaped onto the wire.The balloon was inflated only once before noting balloon was losing pressure during inflation.A cadence syringe was used to inflate the hyperform providing steady inflation rate.

Manufacturer Narrative

H3.Product analysis: equipment used: video inspection system (m-81805), ruler (m-83360) camera (panasonic lumix dmc-zs5), in-house x-pedion guidewire (model: 103-0605-200 lot: 9579797) as found condition: two hyperform occlusion balloon catheters were returned for analysis within a shipping box; within a sealed plastic biohazard pouch; within a different resealable plastic biohazard pouch and further within two individual resealable plastic biohazard pouches.The x-pedion guidewire used in the event was not returned for analysis.It is not possible to determine which balloon belongs to which pli, and therefore will be analyzed together.Visual inspection/damage location details: (first hyperform) no damages or irregularities were found with the hyperform balloon catheter hub.The balloon catheter body was found flattened at ~18.3cm from the distal end and found flattened between ~12.8cm and ~5.0cm from the distal end.No visible damages were found with the balloon subassembly, with the proximal/distal marker bands, or with the distal end.(second hyperform) no damages or irregularities were found with the hyperform balloon catheter hub.The hyperform balloon catheter was found flattened between ~13.1cm and ~6.7cm from the distal end.No visible damages were found with the balloon subassembly, with the proximal/distal marker bands, or with the distal end.Testing/analysis: (first hyperform) the hyperform occlusion balloon catheter was flushed, and water exited out the distal end.An in-house x-pedion guidewire was then inserted into the hyperform.The guidewire was extended out the distal tip ~3cm to test for balloon inflation.The balloon was inflated with no issues and no ruptures or leaks found.(second hyperform) the hyperform occlusion balloon catheter was flushed, and water exited out the distal end.An in-house x-pedion guidewire was then inserted into the hyperform.The guidewire was extended out the distal tip ~3cm to test for balloon inflation.The balloon was inflated with no issues and no ruptures or leaks found.Conclusion: based on the device analysis and reported information, the customer¿s reports of ¿balloon rupture during procedure¿ or ¿contrast exiting the distal end¿ were not confirmed.No ruptures, or pinholes were found on the balloon subassembly and both balloons were inflated with no issues with no leaking found.As the guidewire used in the event was not returned for analysis, any contribution of the guidewire towards the rupture and catheter leak could not be determined.H6.Coding updated based an the analysis results.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 LINE EXTENSION
• Type of Device: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• 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: 15204167
• MDR Text Key: 302580454
• Report Number: 2029214-2022-01341
• Device Sequence Number: 1
• Product Code: MJN
• UDI-Device Identifier: 00763000294298
• UDI-Public: 00763000294298
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2024
• Device Model Number: 104-4715
• Device Catalogue Number: 104-4715
• Device Lot Number: B194417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2022
• Initial Date FDA Received: 08/10/2022
• Supplement Dates Manufacturer Received: 08/10/2022; 10/31/2022
• Supplement Dates FDA Received: 08/24/2022; 11/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 79 KG