MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE FLEX EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER

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

Patient Problem Thromboembolism (2654)

Event Date 09/05/2017

Event Type  Injury  

Manufacturer Narrative

Miyachi, s., hiramatsu, r., ohnishi, h., yagi, r., <(>&<)> kuroiwa, t.(2017).Usefulness of the pipeline embolic device for large and giant carotid cavernous aneurysms.Neurointervention, 12(2), 83.Doi:10.5469/neuroint.2017.12.2.83 the pipeline flex device will not be returned for evaluation as it was implanted in the patient.Based on the reported information, there does not appear to have been any defect of the device during use.The event occurred in the patient post-procedure and its cause could not be conclusively determined from the provided information.Mdrs related to this article: 2029214-2017-01210, 2029214-2017-01211, 2029214-2017-01212, 2029214-2017-01213.

Event Description

Medtronic literature review found a report of an ischemic event after pipeline flex implantation.The purpose of this article was to review the series of patients who underwent treatment with the pipeline embolization device (ped) and to discuss the efficacy and safety of the flow diverter in comparison with other conventional treatment options.The authors identified 24 patients with 24 large or giant, unruptured carotid cavernous aneurysms (cca) treated with ped.The mean age was 71.5 years; 23 patients were female and 1 was male.The article states case 2 ((b)(6), female) underwent placement of five telescoping peds in the treatment of a left cca (28mm) and a tandem aneurysm on the near proximal side.Post-mri showed multiple ischemic lesions due to ¿showered thromboemboli¿.Symptoms included hemiparesis and aphasia, which resolved at one month.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 6994367
• MDR Text Key: 90837639
• Report Number: 2029214-2017-01213
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2017
• 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: 49 YR