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

Model Number	PED-475-30
Medical Device Problem Codes	Unintended Ejection (1234); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that when the stent delivery was not smooth due to resistance in the catheter.When the stent was retracted into the microcatheter, it was found to have great resistance.The stent could not move forward or backwards in the catheter.After repeated attempts, the surgeon pulled off the guidewire of the stent.Neither the stent of microcatheter were implanted, and the stent was removed with the microcatheter.Replacement products were used to complete the procedure.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 retention of contrast agent.The patient was undergoing surgery for treatment of an amorphous, unruptured aneurysm of the cavernous sinus of the right internal carotid artery (ica) with a max diameter of 9.5 mm and a 4.6 mm neck diameter.It was noted the patient's vessel tortuosity was moderate.It was unknown if dual antiplatelet therapy (dapt) was administered.Additional information was received and it was reported that pipeline was inside the microcatheter marksman, and it was unknown whether the stent or push wire or catheter was damaged.
Additional Manufacturer Narrative
Product analysis: as found condition (condition of returned device): a pipeline flex embolization device and a marksman catheter were returned for analysis within a shipping box and within a sealed plastic biohazard pouch.Visual inspection/damage location details: (pli-10) the pipeline flex pushwire was found to be kinked at ~32.8cm and at ~40.0cm from proximal end.The pipeline flex embolization device was found be broken at distal end of hypotube.The ptfe shrink tubing was found intact on broken segment.The proximal bumper, pad and re-sheathing marker were found to be missing.The dps restraints/sleeves, tip coil and braid were found to be missing.Upon further analysis a pipeline pusher segment was found within marksman hub.The segment was then removed from hub.During removal, the distal pipeline segment was inadvertently detached from proximal bumper.The marksman catheter body was then dissected to remove remainder of pipeline.The proximal bumper, re-sheathing pad, and pad restraint were found to be intact.The dps sleeves were found to be intact with contrast and blood residue.The tip coil was found to be damaged.The proximal braid end was found to be collapsed and frayed.The distal braid end was found to be collapsed and frayed.No other anomalies were observed.(pli-20) upon visual inspection, no damages were found with the marksman hub or distal tip.However, the pipeline pusher segment was found within the hub.The pusher segment was then removed from the hub.The marksman catheter body was found to be kinked at ~28.4cm, at ~27.0cm, at ~24.1cm, at ~10.8cm and kinked at ~1.3cm from distal tip.The marksman total length was measured to be 160.7cm (reference 157.0cm).The marksman useable length was measured to be 153.0cm (specification 150.0cm ± 3cm).No other anomalies were observed.Testing/analysis (including sem reports): the broken distal hypotube was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis.The elemental analysis of the broken hypotube end shows fatigue cracking area is visible on the fracture.The fatigue cracking initiated from the wire surface area.The rest of the fracture failed via overload.No other anomalies were observed.(pli-20) the marksman catheter could not be used for resistance testing due to its damaged condition.Conclusion based on the device analysis and reported information, the customer¿s report of ¿resistance/stuck during delivery¿ was confirmed.Possible contributor for resistance is lack of continuous flush during delivery.Based on the returned devices, there was no non-conformance to specifications identified that led to the resistance during delivery issues.Regarding the pushwire broken at distal hypotube, the investigation determined that this event was similar to an event that had already been investigated, regarding the pipeline flex pushwire separation issue; therefore, another investigation is not necessary.Based on the returned device, the customer report of ¿catheter resistance¿ was confirmed.Possible contributors for ¿catheter resistance¿ are ped/delivery system damage, catheter damage, user does not maintain continuous flush, resistance during delivery/retrieval, and user re-sheaths more than two times.Customer reported that patient vessel tortuosity as moderate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX
• Common Device Name: 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: 13062566
• Report Number: 2029214-2021-01656
• Device Sequence Number: 16520514
• Product Code: OUT
• UDI-Device Identifier: 00847536016804
• UDI-Public: 00847536016804
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/06/2024
• Device Model Number: PED-475-30
• Device Catalogue Number: PED-475-30
• Device Lot Number: B157600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female