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

Model Number PED-300-30

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/31/2020

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 distal segment of the pipeline pushwire broke.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the clinoid segment with a max diameter of 9.17mm and a 6mm neck diameter.It was noted the patient's vessel tortuosity was minimal.It was reported that after the pipeline was deployed, it needed to be relocated and adjusted, but couldn't be retrieved.The patient's blood vessels were thin, and the blood vessels at the neck of the aneurysm were curved.The catheter became kinked in the middle section, and when trying to retrieve the pushwire, the distal end broke off.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.Post-procedure angiographic results showed unobstructed blood vessels and dense embolization of the aneurysm.Ancillary devices include a long sheath 8f, 5f navien 115, marksman 150.

Event Description

Additional information received reporting that during deployment the tip of the catheter was moved.The pipeline did not jump.The pipeline was not implanted in the patient and was removed.The broken pushwire was removed within the markman catheter.Another pipeline was used to complete the case.There was no reported harm or injury to the patient.

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

The pipeline flex embolization device and marksman catheter were returned for analysis.No bends or kinks were found with the pipeline flex pusher.The pipeline flex distal hypotube with shrink tubing was found stretched and separated.The pipeline flex pusher total length was measured to be ~189.2cm.The distal pipeline flex pusher was found separated and missing.The marksman catheter was then examined.The marksman catheter total length was measured to be ~157.0cm and the useable length was measured to be ~149.3cm which is within specification (specification: 150cm ± 3cm).No damage was found with the marksman catheter hub.The marksman catheter body was found accordioned from ~29.0cm to ~26.5cm and from ~25.3cm to ~16.0cm from the distal tip.In addition, the marksman catheter outer braids were found protruding from the catheter outer diameter at ~29.0cm from the distal tip.No damage was found with the marksman distal marker/tip.The marksman catheter was flushed, water exited from the distal tip.An in-house 0.026¿ mandrel was inserted into and through the marksman catheter with resistance at the damaged (accordioned) locations.The pipeline flex separated distal segment was not returned.The pipeline flex broken hypotube was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) analysis.Per the analysis report, iron (fe), chromium (cr), and oxygen (o) peaks were detected on the fracture surface.Dimple features observed indicate ductile overload type failure.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s reports of ¿pushwire break/separation¿ and ¿catheter kink/damage¿ were confirmed.The investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary.Regarding the damages found with the returned marksman catheter (accordioning, braid protrusions); it appears high force (pushing and pulling) was used.The investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary.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
• Type of Device: LASER THERAPY PRODUCT
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10358205
• MDR Text Key: 207381749
• Report Number: 2029214-2020-00764
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536014916
• UDI-Public: 00847536014916
• 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: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2022
• Device Model Number: PED-300-30
• Device Catalogue Number: PED-300-30
• Device Lot Number: A886650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 53