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

Model Number PED2-400-16

Device Problems Unintended Ejection (1234); Positioning Problem (3009); Unintended Movement (3026)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/08/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received a report that, when attempting to release the pipeline, the physician lost control causing the pipeline to be open prematurely and be released in the wrong place, close to the lap.To complete the procedure a second more distal pipeline was placed.The patient was undergoing surgery for treatment of a saccular ica aneurysm that ruptured in (b)(6) 2019, with a max diameter of 12mm and a neck diameter of 4mm.There was no friction during procedure, the pushwire was not rotated or pulled back at any time during the procedure.Dual antiplatelet treatment was administered.Post procedure angiographic results showed good results.There were no related patient symptoms.Describe when premature deployment occurred.There was no friction or difficulty during delivery or positioning, the pipeline did not jump during deployment.The delivery wire dropped from the pipeline in the middle of the release, for this reason the physician had to remove the marksman and the pipeline was accommodated very close to the neck of the aneurysm.

• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 8659544
• MDR Text Key: 146810926
• Report Number: 2029214-2019-00503
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Model Number: PED2-400-16
• Device Catalogue Number: PED2-400-16
• Device Lot Number: A760122
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2019
• Date Device Manufactured: 01/02/2019
• 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): Other
• Patient Age: 29 YR