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

Model Number 104-4770

Device Problem Burst Container or Vessel (1074)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/14/2020

Event Type  malfunction  

Manufacturer Narrative

Since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.No corrective action.Monitoring and trending this type of event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the medtronic balloon ruptured while post ballooning.Another hyperform was used to complete the procedure.No patient injury was reported as a result of the event.Prior to the event, a stent was deployed.Then the balloon was used, and the reported event occurred.

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 hyperform balloon was used to provide better wall apposition for the pipeline in the vessels.There were no problems with the pipeline opening.The physician had tested the balloon prior to use, and it had performed as intended.The physician had not shaped the guidewire tip.The balloon leak was in the middle, and the rupture occurred on the first inflation attempt.The injection rate was slow, and the patient's vessel tortuosity was normal.

Manufacturer Narrative

The guidewire was examined.No bends or kinks were found with the pushwire.The guidewire proximal and distal solder regions were found to be in good condition.The guidewire distal tip was found curved but undamaged.No damages were found with the hyperform hub.No bends or kinks were found with the hyperform catheter body.Upon visual inspection, no damages were found with the hyperform balloon distal tip.The hyperform occlusion balloon catheter was flushed and water did not exit the distal end as it was found to be occluded.The returned guidewire was inserted into the hub and became stuck at ~30.0cm from the proximal end.An in-house mandrel was inserted and became stuck at the same location.Unknown fibers were found stuck to the mandrel during retraction.The balloon catheter was cut past the occlusion and a mandrel was used to occlude the distal end.An attempt was made to inflate the hyperform balloon; however, the balloon could not maintain inflation as it was found leaking distal to the distal marker.Upon microscopic inspection, a defect (tear) in the balloon chronoprene tubing was observed at the distal tip.No other anomalies were observed.There was no indication that the event was related to a potential manufacturing issue.Based on the device analysis and reported information, the customer¿s report of ¿balloon rupture during procedure¿ was confirmed as a tear was found on the distal end of the balloon; however, the cause for the damage could not be determined as there is insufficient information.Possible causes for balloon rupture are over inflation or balloon was inflated after receiving mechanical damage.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; irvine CA 92618
• MDR Report Key: 10418183
• MDR Text Key: 209383746
• Report Number: 2029214-2020-00810
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• PMA/PMN Number: K091458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2020

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: 11/14/2020
• Device Model Number: 104-4770
• Device Catalogue Number: 104-4770
• Device Lot Number: A749045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 08/17/2020
• Supplement Dates Manufacturer Received: 08/18/2020; 10/24/2020
• Supplement Dates FDA Received: 08/31/2020; 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1