MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE; LASER THERAPY PRODUCT

Model Number PED-400-25

Device Problems Break (1069); Activation Failure (3270); Physical Resistance/Sticking (4012)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/14/2020

Event Type  Injury  

Manufacturer Narrative

The devices involved in the event has not been returned; therefore the event cause could not be determined.Correspondence has been sent out for return of the device.Once the device has been received and investigation completed.A supplemental report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the medtronic flow diverter middle and proximal section had difficulty opening and the distal pushwire separated from the position behind the recovery pad in the medtronic microcatheter.Prior to the event, the physician was in the process of releasing the medtronic flow diverter to the middle section of the medtronic microcatheter and then the reported event occurred.Resistance was felt in the distal part of the microcatheter during release of the flow diverter.After the distal pushwire broke, there was no more resistance felt.The pushwire was repeatedly manipulated to try to open the middle and proximal section of the flow diverter, but the proximal side could not be opened.Finally, the endoscope biopsy forceps were used to clamp the flow diverter to the recovery pad.Then the flow diverter was then push and pulled in order to release the flow diverter and the proximal end of the flow diverter was finally opened.The synchro guidewire could not reach the distal part through the medtronic flow diverter to retrieve the broken distal pushwire.The physician decided to leave the broken distal pushwire inside the patient and the surgery was completed.The tip of the medtronic microcatheter was observed to be accordioned after it was removed from the patient.The patient was awake after the surgery with stable signs.The patient had grade 4 upper muscle strength on the affected side and was in good condition to be released already.

Manufacturer Narrative

H6: codes updated as received, the proximal segment of the pushwire was returned.The pushwire appeared to be separated at distal hypotube.The pipeline flex braid and distal broken segment were not returned as they were remained inside the patient.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The outer jacket on the hypotube appeared to be damaged and pulled back from the broken end.Bends were observed from the proximal end of the pushwire.Based on the returned device, the pipeline flex was not confirmed to have failure to open issues as the pipeline flex braid was not returned as it was remained in the patient.However, the pipeline flex was confirmed to have resistance during delivery and separation at the distal hypotube.The device was under legal hold.No destructive analysis was allowed.¿ therefore, the broken end could not be cut to send out for sem analysis.The failure was at the distal hypotube not the solder failure.Furthermore, the damages seen on the catheter body (flattening/accordioning), pusher (bending), hypotube (stretching) and shrink tube jacket (damaging); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance/retrieve the pipeline flex through the catheter against resistance.It is likely that the severe vessel tortuosity have contributed to the resistance during delivery; subsequently causing the pushwire become stretched and separated.It is possible that the pushwire separation is likely due to tensile failure.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

H3: per the core tech results: "flat fracture surface, mostly brittle with straight line features.Very little ductility." 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: PIPELINE FLEX EMBOLIZATION DEVICE
• Type of Device: LASER THERAPY PRODUCT
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9661333
• MDR Text Key: 188889340
• Report Number: 2029214-2020-00095
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S011
• 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: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2022
• Device Model Number: PED-400-25
• Device Catalogue Number: PED-400-25
• Device Lot Number: A920066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Date Manufacturer Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 48 YR
• Patient Weight: 55