MAUDE Adverse Event Report: MEDTRONIC PIPELINE FLEX EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number NV UNK FLEX

Device Problem No Apparent Adverse Event (3189)

Patient Problems Intracranial Hemorrhage (1891); Cognitive Changes (2551)

Event Date 05/01/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Oguz s, tabakci ön, uysal e, bulut e, dinç h.Pipeline flex embolization device (ped flex) for the treatment of intracranial aneurysms: periprocedural outcomes and first-year angiographic results. turkish journal of medical sciences.2019;49(6):1640.Http://search.Ebscohost.Com/login.Aspx?direct=true<(>&<)>db=edb<(>&<)>an=140821945<(>&<)>site=eds-live.Accessed march 16, 2020.Medtronic received a report regarding a study to evaluate the efficacy of the pipeline flex device.The authors reviewed 49 patients with a mean age of 52 years, 63% female.The average aneurysm diameter was 8mm.Intraprocedural or periprocedural thromboembolic events occurred in four patients.All these presented with minor neurological deficits, and there were no clinical deficits at discharge.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9836772
• MDR Text Key: 190148199
• Report Number: 2029214-2020-00234
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NV UNK FLEX
• Device Catalogue Number: NV UNK FLEX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 03/16/2020
• 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: 52 YR