MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED2-450-20

Device Problems Break (1069); Unintended Ejection (1234); Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 07/11/2022

Event Type  malfunction  

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 information that a ped2 pipeline failed to open and had issues resheathing with a phenom 27 and navien catheters.A flow diverter stent placement surgery was performed in the right internal carotid artery (ica) c4/7 mm intra-curve inlet side aneurysm.The optimo 9fr, which was prepared as per the package insert, was placed in the rt-ic; the navien 5fr 125 cm, which was prepared as per the package insert, was delivered near the neck of the rt-ica-c4 aneurysm.Phenom 27 was delivered to m1 using chikai 14 wire after preparation as per the package insert.Ped4.5*20 which was prepared as per the package insert was delivered inside the phenom27 and it was delivered until the tip region of phenom 27.As recommended in the package insert, the sleeve was removed from the tip of phenom 27 (first full resheath) on the middle cerebral artery (mca); it was dragged down and pulled down to the target lesion with system pull; then it was tried to be deployed using a wire push.After the sleeve was removed, the distal-end region was nea tly deployed, but a deployment defect occurred in the first curve.Everything was tried to get rid of the deployment failure, but the stent did not expand at all.(resheath, wire push/system push/system pull/unsheath, deployment within navien, push-pull with navien, vibration massage, etc.) for the stent deployment failure part on the 1st curve, since there was no sign of expansion, an attempt was made to full resheath the pipeline inside the phenom, and a system pull with the phenom + pipeline inside the navien was attempted, and a strong resistance was felt.The pipeline could not be stored in the navien with a strongly crushed expanded state; a strong resistance was felt, but a system pull was performed as is.(at this time, it is predicted that the implant part of the pipeline stent was disconnected from the core wire even though the phenom tip marker has not yet reached the resheath limit point.) as a result, full resheath of the pipeline stent in the phenom was not possible.It was confirmed that the movement of the core wire and the pipeline stent did not move at 1:1., and that the pipe stent was disconnected from the core- wire.To collect all the pipe stents that have been deployed incompletely outside the body, the pipe core wire, and the phenom was locked and fixated.Then the navien was pushed and inside navien in order to collect the pipe stent, storage was attempted.As a result, this method was effective, and it was possible to store all the pipe stents inside the navien.With the phenom + pipe stent still stored in the navien, the entire device could be removed from the body.(*no residue in the body.) afterwards, an attempt was made to collect the pipe stent implant inside the navien tip, but the stent could not be collected outside the navien.As such, the navien 5fr 125 and phenom 27/160 were newly opened, prepared as per the package insert, and delivered to the ica in the same manner.Phenom27 was delivered to mca, a new ped 4.5*20 of the same size was opened, prepared as per the package insert and the procedure was continued.The newly opened navien 5fr/125-phenom27/160-ped4*20 was deployed without any problems, and the procedure was completed safely.No unnecessary device remains in the body.The pipeline deployment failure was in the distal region.The distal region of the pipeline was positioned in a bend less than 50% had been deployed when it failed to open.The pipeline was resheathed 2 times or less.There was premature stent expansion.The catheter was flushed as indicated in the instructions for use (ifu).  the patient was being treated for an unruptured, saccular aneurysm in the right ica c4.The max diameter was 7mm and the neck diameter was 6.6mm.The distal landing zone was 4.14mm and the proximal landing zone was 4.37mm.The vessel tortuosity was strong.The access vessel was 4.5mm.No symptoms or complications were reported.

Event Description

Additional information received reported that during the procedure, the push wire was repeatedly pressed and pulled back.The distal and the edge of the middle of the body did not open.It was noted that the pipeline was placed in the vessel bend.

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.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• 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: 15179707
• MDR Text Key: 301556435
• Report Number: 2029214-2022-01309
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100018
• 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
• Report Date: 08/24/2022

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 Model Number: PED2-450-20
• Device Catalogue Number: PED2-450-20
• Device Lot Number: B309226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 08/05/2022
• Supplement Dates Manufacturer Received: 08/08/2022
• Supplement Dates FDA Received: 08/24/2022
• Date Device Manufactured: 12/08/2021
• 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: 68 YR
• Patient Sex: Female