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

Model Number PED2-250-20

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received information that pipeline flex with shield device stuck/lock inside the xt 27 catheter and tip of the pipeline broke.The catheter was damaged.The device was removed intact and did not affect the patient, no injury was reported.The procedure as completed with a replacement product.The patient underwent embolization treatment for an unruptured saccular aneurysm was located cerebral artery.Measuring 4.6mmx3.6mm.Landing zone distal 2.1mm proximal 2.3mm.The vessel was observed severely tortuous.It was reported that during the procedure and due to the tortuosity of the patient's arteries, the xt27 microcatheter elongated causing the entrapment of the pipeline flex shield flow diverter.Pipeline stuck at the distal section of the catheter.In addition to the tip coil of the diverter it was observed fractured in the fluoroscopy image, which also it prevented the specialist doctor from advancing the device.There were not any patient symptoms or complications associated with this event.No medical or surgical intervention needed to prevent a permanent impairment of a function.The event did not lead or extended patient hospitalization.Dapt (dual antiplatelet treatment) was administered.The pipeline and any accessory devices were prepared as indicated in the ifu.The catheter flushed as indicated in the ifu.No patient injury was reported.The catheter flushed continuously with heparinized saline.Ancillary devices include an xt27 microcatheter.Xt 27 catheter.

Manufacturer Narrative

D10: device available for evaluation - additional information g4.Date mfr rec ¿ additional information h2: type of follow up - device evaluation h3: device evaluated by manufacturer- additional information h6: codes updated the device was returned for evaluation and the clinical observation was confirmed.As received, the pushwire appeared to be broken at proximal to the dps sleeves.The tip coil, dps restraints and sleeves were not returned.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The pipeline flex shield braid was fully opened and no damage.Kinks and bends found from the proximal end of the pushwire.The broken end sent out for scanning electron microscopy / energy dispersive x-ray spectroscopy (sem/eds) analysis.Based on the analysis findings and sem/eds analysis, the pipeline flex with shield was confirmed pushwire separation.The fracture surface exhibits dimple features consistent with torsional overload failure mechanism.From the damages seen on the pushwire (kinking/bending) and hypotube (stretching); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance the pipeline flex shield through the non-medtronic catheter against resistance.It is likely that the severe vessel tortuosity may contributed to the resistance during delivery; subsequently causing the pushwire to separate.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 EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9137894
• MDR Text Key: 168452665
• Report Number: 2029214-2019-00967
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

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 Expiration Date: 01/11/2020
• Device Model Number: PED2-250-20
• Device Catalogue Number: PED2-250-20
• Device Lot Number: A399110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 09/30/2019
• Supplement Dates Manufacturer Received: 11/15/2019
• Supplement Dates FDA Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 90 YR
• Patient Weight: 68