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

Model Number PED2-300-16

Device Problems Break (1069); Unintended Movement (3026)

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

Event Date 05/26/2021

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 pipeline moved during deployment and the pushwire broke while resheathing.The patient was undergoing treatment for an unruptured, saccular choroidal aneurysm.The max diameter and neck diameter were 2mm.The patient's vessel tortuosity was moderate.The landing zone was 2mm distal and 3mm proximal.The access vessel was the femoral artery, which was 6mm in diameter. dual antiplatelet treatment was administered, and the pru level was 120.It was reported that the microcatheter was advanced to the distal portion of the middle cerebral artery m1.The pipeline was advanced and positioned in the middle cerebral artery, and release began from m1.When the third part of the device had been released and was in the communicating segment, the device underwent a retraction and was positioned below the choroid aneurysm, so the doctor decided to resheath the pipeline to reposition it.When trying to resheath it, the device suffered distal guide detachment without being able to recapture the mesh and was trapped in the phenom microcatheter.It was decided to maneuver by successfully recovering the entire device system with the sofia catheter. the device was replaced, and the patient did not experience any injury or complications. control images performed showed normal flow without brain damage. no additional medical or surgical interventions was needed, and the patient was not hospitalized as a result of the event.Angiographic results post procedure were normal without complications. the devices were prepared and flushed according to the instructions for use (ifu).Ancillary devices include a traxcess guidewire, sofia catheter, phenom 027 microcatheter, and 6fr iva inserter.

Manufacturer Narrative

B5.Updated with additional information received.G3: pma/510(k) corrected.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 the pushwire separated from the stent when first attempting to recapture.There was no friction or difficulty with repositioning.

Manufacturer Narrative

As found condition (condition of returned device): a pipeline flex embolization device and a phenom catheter were returned for analysis within a shipping box; within a sealed tyvek biohazard pouch and within a sealed plastic biohazard bag.Visual inspection/damage location details: no device malfunction was reported for the phenom-27 catheter.The pipeline flex delivery system was returned within the phenom catheter.The pipeline pushwire was found to be extending ~44.1cm from hub and ~1.4cm from distal tip.The pipeline flex delivery system was then attempted to be removed from the phenom-27 catheter; however, the attempt was unsuccessful.The catheter was then dissected (cut) and the pipeline flex device was revealed.No bends or kinks were found with the pipeline flex pushwire.The distal hypotube and ptfe were found to be intact and with blood residue.The proximal bumper, re-sheathing marker and re-sheathing pad were found to be intact.The dps sleeves were found to be intact and appeared to have blood residue.The tip coil was found to be intact.The proximal braid end was found to be collapsed and frayed and inadvertently damaged during dissection of phenom catheter.The middle section of braid was found to be collapsed with blood residue.The distal end of braid was found to be opened and frayed.No other anomalies were observed.(pli-20) the phenom-27 catheter total length was measured to be ~157.4cm (reference 156.5cm).The phenom useable length was measured to be ~150.9cm which is within specification (specification: 150.0cm ± 5cm).Upon visual inspection, no damages were found with the phenom hub.The catheter body was found to be flattened at ~3.8 for ~2.0cm, kinked at ~1.6cm from distal tip.No damage was found with the distal tip.There was no indication that the event could be related to a potential manufacturing issue; therefore, a device history record review does not need to be performed.Testing/analysis: the phenom-27 catheter was unable to be used for resistance testing with an in-house mandrel due to its damaged co ndition.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿movement during deployment¿ was unable to be confirmed and the root cause was unable to be determined.Possible contributors for ¿movement during deployment¿ are patient vessel tortuosity, high delivery force or incorrect braid sizing.The customer reported vessel tortuosity was moderate.Based on the device analysis and reported information, the customer¿s report of ¿pushwire break/separation¿ was unable to be confirmed as no damages were found with the pushwire.Possible contributors towards failure are patient vessel tortuosity, or user re-sheaths more than two times.Customer reported patient vessel tortuosity as moderate.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
• MDR Report Key: 11903110
• MDR Text Key: 254028492
• Report Number: 2029214-2021-00637
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S026
• 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: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2024
• Device Model Number: PED2-300-16
• Device Catalogue Number: PED2-300-16
• Device Lot Number: B154678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Date Manufacturer Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 60