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

Model Number PED2-275-20

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

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

Event Date 08/04/2023

Event Type  malfunction  

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

Medtronic received a report that the guidewire of the pipeline shield stent was broken and stuck during delivery.The pushwire broke in the middle section.The phenom catheter experienced resistance in the middle section of the catheter.The pipeline was not used for an off-label use.The pipeline and any accessories were prepared as indicated in the instructions for use (ifu).The phenom catheter was flushed as indicated in the ifu.The post procedure angiographic result showed an intracranial aneurysm.No patient symptoms or further complications were reported as a result of this event. the patient was undergoing surgery for treatment of a saccular, unruptured intracranial segment of the internal carotid artery aneurysm.The patient also underwent a blood flow diversion stent implantation.The patient's access vessel was the femoral artery.Dual antiplatelet therapy (dapt) was administered.

Manufacturer Narrative

H3: product analysis #705751950:¿ equipment used: video inspection system (m-78210), ruler 200cm (m-83361) and in-house 0.0265in mandrel ¿ drawing(s) referenced: dwgsfg15xxx-yyyy-zz rev.F ¿ as found condition: the pipeline flex shield braid and phenom 27 catheter were returned for analysis within a shipping box; and within a plastic bio-pouch.The pipeline flex sheild pusher was not returned for analysis.Therefore, any contributing factors could not be assessed.¿ damage location details: the distal and proximal ends of the pipeline flex sheild were found fully opened and moderately frayed.No flash or voids molded were observed in the hub.The catheter body was found to be accordioned from ~3.4cm to the distal tip.The phenom 27 catheter distal tip and marker band were found accordioned.No other anomalies were observed.¿ testing/analysis: the total and usable lengths of the catheter were measured to be within specifications.The pipeline flex shield braid was pushed out from catheter without issues.The catheter was flushed with water and water exited out of the distal tip.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 with no issues; however, the resistance observed at the damaged locations.¿ conclusion: based on the analysis findings, the pipeline flex sheild and phenom 27 catheter were confirmed to have resistance.However, the pipeline flex shield was not confirmed to have pushwire break/separation as the pushwire was not returned for analysis.The pipeline flex sheild and the phenom 27 catheter were found to be damaged.From the damages seen on the catheter body (accordioning), and pipeline flex shield braid (fraying); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance and retrieve the pipeline flex sheild through the phenom 27 catheter against resistance.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
• 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: 17687171
• MDR Text Key: 322715781
• Report Number: 2029214-2023-01566
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00763000283940
• UDI-Public: 00763000283940
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/06/2023

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 Model Number: PED2-275-20
• Device Catalogue Number: PED2-275-20
• Device Lot Number: B554016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 09/09/2023
• Supplement Dates FDA Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2023
• 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 Age: 54 YR
• Patient Sex: Female