MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 MARKSMAN; CATHETER, CONTINUOUS FLUSH

Model Number FA-55150-1030

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the first marksman catheter used broke into 4 parts at the distal section during the delivery of the first pipeline.It was stated that severe resistance was encountered in the distal section of the first catheter during the delivery.It was found that the first pipeline's hypotube and pushwire had a kink on the proximal section.The rebar catheter was used to to deliver the micro snare, and was able to remove the entire system and broken distal catheter tip from the patient.Another marksman catheter and pipeline were used; however, the catheter's distal tip broke again during delivery.Through the sofia catheter, the distal tip of the catheter and pipeline system, which was trapped inside, was rescued.There was no other damage to the catheters aside from the rupture.It was noted that the catheters was continuously perfused in a pressure bag.The catheter was flushed continuously with heparanized saline.There was no friction or difficulty during injection as well as no force applied during delivery or removal.The first catheter was entrapped/stuck; however, it was not stuck inside the guide catheter.There was no vasospasm.Implantation of the third pipeline had no complications.Angiographic result post procedure showed satisfactory angiographic control with no signs of hemorrhage, ischemia, or adverse events.Dapt (dual antiplatelet treatment) was administered with the pru level stated as aas + clopidogrel.The patient was undergoing surgery to treat an unruptured, saccular aneurysm at the basilar artery with a max diameter of 22 mm and a neck diameter of 12 mm.The lesion/vessel site or location associated with the event was subclavian artery.It was noted the access was through the right radial artery as the aneurysm was at the top of the basilar artery and the aortic arch had very poor anatomy for femoral access.The location within the artery was distal.It was noted the vessel tortuosity was severe.It was stated the vertebrals were dysplastic and very tortuous.There were no patient symptoms associated with the event.The patient's medical history included hypertension and embolization of the basilar top aneurysm with coils and lvis stent.The devices were prepared as indicated in the ifu.It was noted that the devices were used for an indication not approved in the us; however, it was approved in (b)(6).

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 indicated there was no damage to the microsnare.The product was only segregated because it was composing the system that was removed from the patient: fractured marksman distal tip and pipeline.

Manufacturer Narrative

H3: the marksman catheter (model: fa-55150-1030 lot: 218771378) (pli-10), pipeline flex embolization device (model: ped2-400-30 lot: a868568) (pli-20) and a marksman catheter (model: fa-55150-1030 lot: 218867567) (pli-30) were returned for analysis.(pli-10) upon visual inspection, the marksman catheter was returned in 4 segments.The first segment, which includes the hub and strain relief, total length was measured to be 7.6cm.No damages were found with the marksman hub.The catheter body was found to be separated at the strain relief.The separated second segment total length was measured to be ~20.2cm.It appeared to be skived and damaged at distal end.The third segment total length was measured to be ~51.2cm.Both proximal and distal ends of third segment were found to be damaged (separated/cut).The fourth segment total length was measured to be ~55.4cm.Both proximal and distal ends of fourth segment were found to be damaged (separated/cut).The distal tip was found to be missing.The marksman total length and useable length were unable to be measured due to its damaged condition.The marksman micro catheter could not be used for resistance testing with an in-house mandrel due to its damaged condition.(pli-20) the pipeline flex pushwire was found to be bent at ~33.2cm from proximal end.The hypotube was found to be intact.The ptfe shrink tubing was found to be pulled back.The proximal bumper, pad and re-sheathing marker were found intact.The dps restraints/sleeves were found to be intact.No damages were found with the tip coil.Due to the conditions in which the braid was returned the proximal and distal ends were unable to be determined.Both braid ends were found to be opened with braid end 1 being frayed.No other anomalies were observed.(pli-30) upon visual inspection, the marksman catheter was returned in 2 segments.No damages were found with the marksman hub.The total length of the first segment was measured to be ~130.2cm.The second segment was measured to be ~32.9cm.The catheter body was found to be damaged (separated/cut) at distal end of first segment.The distal segment was found to be stretched and damaged at proximal end.The inner lining and inner coil were found to be extending from the damaged proximal end.No damages were found with the distal tip.The marksman total length and useable length were unable to be measured due to its damaged condition.The marksman micro catheter could not be used for resistance testing with an in-house mandrel due to its damaged condition.There was an indication that the event could be related to a potential manufacturing issue; therefore, a device history record review was performed.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.Based on the device analysis and reported information, the customer¿s report of ¿resistance/stuck during delivery¿ was confirmed.The investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary.Based on the investigation conducted resistance can occur during tracking, deployment and re-sheathing of the device in distal and tortuous anatomies.In addition, resistance can occur due to patient vessel tortuosity, failure to maintain a continuous flush, or pipeline is pulled back/torqued during delivery.The vessel anatomy was moderate in tortuosity and a continuous flush was maintained.Therefore, the cause could not be determined.Based on the analysis findings, the customer report of ¿resistance/stuck during delivery¿ was confirmed.The returned pipeline flex device damages (braid frayed) are indicative of high force used.It is likely the damage occurred when the customer attempted to advance the pipeline flex through the marksman catheter against the reported resistance.Based on the device analysis and reported information, the customer¿s report of ¿catheter resistance¿ could not be confirmed due to the marksman catheters damaged condition.The cause for the damage could not be determined.Based on the device an alysis and reported information, the customer¿s report of ¿pushwire kink/damage¿ was confirmed as the pushwire was found to be bent.It is possible the damages occurred when the customer attempted to advance/retrieve the pipeline through the marksman catheter against resistance.Based on the device analysis and reported information, the customer¿s report of ¿catheter separation/break¿ was confirmed as the marksman catheters were found to be separated.The cause for the damage could not be determined.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: MARKSMAN
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10759591
• MDR Text Key: 214802632
• Report Number: 2029214-2020-01075
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00836462014077
• UDI-Public: 00836462014077
• Combination Product (y/n): N
• PMA/PMN Number: K091559
• 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: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FA-55150-1030
• Device Catalogue Number: FA-55150-1030
• Device Lot Number: 218771378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 62