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

Model Number FG15150-0630-1S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Perforation of Vessels (2135)

Event Date 07/14/2022

Event Type  Injury  

Event Description

Medtronic received information regarding two pipeline shield stents that failed to open and the patient's vessel was perforated causing fistula.The patient was undergoing a procedure for flow diverter treatment of an unruptured amorphous left internal carotid artery (ica) supraclinoid aneurysm.The aneurysm max diameter was 4mm and the neck diameter was 3mm.Vessel tortuosity was moderate.Dual antiplatelet treatment (dapt) was administered with pru level 80.It was reported that the devices were prepared as indicated in the instructions for use (ifu).The rist guide catheter was placed int he patient's left ica and the phenom 27 microcatheter was guided to the aneurysm location with the non-medtronic guidewire.The pipeline was flushed with heparinized saline in the introducer sheath and then was delivered and deployed in the middle cerebral artery (mca).The pipeline 5x18 was unsheath and pushed with the pushwire to deliver the pipeline across the aneurysm.When the pipeline was less than 50% deployed, the distal end failed to open.The pipeline still could not be opened event after centering the microcatheter and resheathing up to the ptfe sleeves.The surgeon attempted "wagging" the pipeline without success.The pipeline was resheathed and removed with the microcatheter; it was noted the pipeline was resheathed 2 or less times.Another pipeline, a 4.75x18, was then prepped to be delivered.However, before insertion, angiogram was performed of the left ica noting carotid cavernous fistula, thought potentially to be from the guidewire, and extravasation outside the left ica was observed.The pipeline 4.75x18 was deployed successfully but extravasation from the perforation was still unchanged so the surgeon decided to place another pipeline in the suspected area of perforation.A pipeline shield 4.75 x20 was selected.As with the first pipeline, the 4.75 x 20 pipeline, the 4.75x20 pipeline failed to open despite resheathing, forward loading, "wagging", and balloon angioplasty.The pipeline was resheathed and removed with the microcatheter and was replaced with a pipeline shield 5x14 which was delivered and deployed successfully within the implanted 4.75x18 pipeline.The surgeon was then better able to visualize where the perforation originated, which was just proximal to both implanted pipelines.The surgeon implanted 10 embolic coils into the extravascular spaced then implanted one final pipeline shield (4.75x14, lot: b375265) proximal to and within both previously implanted pipelines, covering the perforation site.The patient was stable and doing well post-operatively.Ancillary device: boston scientific v18 guidewire.

Manufacturer Narrative

Associated with rr #: 2029214-2022-01348, 2029214-2022-01349, and 2029214-2022-01350.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.One microcatheter not mentioned before was the use of a phenom 27 160cm (accidentally pulled by the circulating technologist) at the beginning of the case and with the fathom 16 180 cm wire (boston scientific) used and being too short, a cordis v18 wire was used and the possible cause of the initial perforation of the ica.The initial pipeline shield stent delivered not opening through the phenom 27 160 mc and being removed became stuck within the mc , the phenom 27 160cm mc was then completely removed and replaced with a phenom 27 150cm mc.Initial report was focused on the quality assurance issue of the pipeline stents, but after reviewing with the tech about the phenom 27 160 mc he said the boxes for the phenom lengths 150cm and 160cm look exactly alike leading to an 18 wire being used instead of the standard 16 wire.

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

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 was received that the patient is recovering without symptoms.Actions taken to resolve the fistula was a pipeline and coils were placed across rest of fistula to seal the opening.The distal segments of the pipelines were having issues fully opening.The pipeline was not placed in a vessel bend when it failed to open.

• Brand Name: CATHERA
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: 15213917
• MDR Text Key: 297764032
• Report Number: 2029214-2022-01351
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00763000399719
• UDI-Public: 00763000399719
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FG15150-0630-1S
• Device Catalogue Number: FG15150-0630-1S
• Device Lot Number: 221388472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 64 KG