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

Model Number PED-375-16

Device Problems Material Deformation (2976); Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 11/18/2020

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 marksman microcatheter was in place, and the pipeline was delivered.The patient's blood vessel at this point was moderately tortuous, and during deployment, there was a large resistance in the middle section of the catheter.The corner of the middle section of the stent could not open during deployment.The pipeline and catheter were removed from the body, and it was found the marksman catheter had multiple accordions and the proximal section of the pipeline pushwire was bent.It was noted a continuous flush was used in the procedure.Replacement products were used to complete the procedure with no further issues reported.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.The patient was undergoing surgery for treatment of saccular, unruptured aneurysms of the left internal carotid artery.It was noted the patient's vessel tortuosity was moderate.Ancillary devices include a 5f 155 navien, marksman microcatheter.

Event Description

Additional information received reporting that the middle section of the pipeline which failed to open was positioned in a vessel bend.It was unknown how many times the pipeline was resheathed.The physician also attempted to "swing" the microcatheter and pipeline together to open the pipeline without success.

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

H3: analysis of the pipeline flex (lot no.B066369) and marksman microcatheter (lot #: 218379404) found that the distal and proximal dps restraints were intact.The dps sleeves were found intact with no signs of damage.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The distal and proximal ends of the pipeline flex braid were found fully opened and moderately frayed.In addition, the middle section of the braid was found fully opened and no damage.Bends were found at 28.0 cm to 40.0 cm from the proximal end.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The total and usable lengths of the marksman catheter were measured to be within specifications.The catheter tip and marker were examined; no damages were found.The catheter body appeared to be accordioned at 21.0 cm to 31.5 cm from the distal tip.No flash or voids molded were observed in the hub.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel successfully passed through the catheter hub and tip; however, resistance was observed at the damaged locations.No other anomalies were observed.Based on the returned devices, the pipeline flex and marksman catheter were confirmed to have ¿resistance during delivery¿ and ¿catheter resistance¿ issues as the returned pipeline flex and marksman catheter were damaged.From the damages seen on the catheter (accordioning), pusher (bending), pipeline flex (fraying) and hypotube (stretching); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance the pipeline flex through the marksman catheter against the resistance.However, the cause of resistance could not be determined.Regarding the "failure to open at the middle section" issue, the customer complaint was not confirmed as the middle section of the pipeline flex braid was found fully opened and no damage.Additionally, the distal and proximal ends of the braid were found fully opened and frayed.The damage to the braid on the ends of the pipeline flex braid is likely the results of the physician re-sheathing the device more than recommended two times.Possible causes include patient's vessel tortuosity and lack of continuous flush with heparinized saline during procedure.There was no non-conformance to specifications identified that led to the reported issues.H6: method code updated to b01.Result code updated to c0702 and c070601 conclusion code updated to d15.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

No additional information received.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10878223
• MDR Text Key: 219521438
• Report Number: 2029214-2020-01160
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536015609
• UDI-Public: 00847536015609
• 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: 02/08/2021

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: 08/07/2023
• Device Model Number: PED-375-16
• Device Catalogue Number: PED-375-16
• Device Lot Number: B066369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 11/25/2020; 01/28/2021
• Supplement Dates FDA Received: 12/10/2020; 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR