MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; LASER THERAPY PRODUCT

Model Number PED2-425-35

Device Problem Break (1069)

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

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the tip coil of the pipeline pushwire broke off during deployment.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the right va with a max diameter of 8.16mm and a 5-6mm neck diameter.It was noted the patient's vessel tortuosity was severe.Dapt (dual antiplatelet treatment) was administered at normal guidelines of the hospital.It was reported that the mach 1 and phenom 27 were used to gain access by synchro to basilar artery through the right va.The pipeline was then loaded into the phenom 27.While deploying a third of the pipeline, the distal tip coil broke off the pushwire and moved to a more distal part of the basilar artery.The distal part of the pipeline was dropped inside the va aneurysm.The surgeon shot several dsa to confirm the location of the broken part of the tip coil and theremaining pipeline.Afterward, the team decided to continue with the deployment of the pipeline, and the remaining deployment was smooth.Once deployed, the surgeon removed the pushwire and used a microsnare to retrieve the tip coil in the basilar artery.About a half hour was used to retrieve the tip successfully.The final dsa showed a little bit of stasis of the pipeline even though it wasdropped inside the wide neck aneurysm, and the blood flow was normal for posterior cerebral circulation.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Ancillary devices include a mach 1 sheath, phenom 27 150cm, synchro guidewire, ev3 amplatz goose neck microsnare kit sk400.

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 there was no friction or difficulty during delivery or positioning.The pipeline shield was implanted and remains in the patient.

Manufacturer Narrative

H3: the pipeline flex distal hypotube does not appear to be stretched.The pipeline flex separated distal segment was found bent proximal to the resheathing marker.The proximal bumper, resheathing pad, resheathing marker, ptfe sleeves, distal marker and tip coil were found in good condition.The pipeline flex broken hypotube was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) analysis.Per the analysis report, iron (fe) and chromium (cr) were detected on the fracture surface.Some fracture surfaces exhibit corrosion damage.Dimple features indicative of ductile overload type failure are visible in the intact areas.Based on the device analysis and reported information, the customer¿s reports of ¿pushwire break/separation¿ was confirmed.Based on the formal investigation conducted, pushwire separation can occur due to certain use conditions such as excessive force and patient vessel tortuosity.In this event it is likely the patient¿s ¿severe¿ vessel tortuosity contributed to the event.Regarding the bent condition of the pipeline flex distal segment this was likely caused by the microsnare used to retrieve this segment from within the patient.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.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Type of Device: LASER THERAPY PRODUCT
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10416896
• MDR Text Key: 204393108
• Report Number: 2029214-2020-00807
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• 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: 06/11/2022
• Device Model Number: PED2-425-35
• Device Catalogue Number: PED2-425-35
• Device Lot Number: A846924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 08/17/2020
• Supplement Dates Manufacturer Received: 08/17/2020; 11/04/2020
• Supplement Dates FDA Received: 08/31/2020; 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29 YR