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

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Activation Failure (3270)

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

Event Date 06/25/2015

Event Type  malfunction  

Event Description

Medtronic (covidien) received information from literature review that 4 pipeline embolization device did not open completely (2 proximally and 2 distally), 3 cases of incomplete ped wall apposition, 1 case of distal wire fracture.No other information provided regarding these device technical complications.In this paper, the authors reported the feasibility, safety, and outcomes associated with the use of the ped for intracranial aneurysms performed in awake patients after the administration of conscious sedation (cs) and local anesthetic.Between (b)(6) 2012 and (b)(6) 2014, 130 patients with 139 intracranial aneurysms (8 ruptured) were treated with the ped under cs at the authors' institution.During the study period, 130 patients (mean age, 56.16 years; range, 19-82 years; 57 men and 73 women) with 139 aneurysms were successfully treated.Eight of these aneurysms were ruptured and treated in the acute phase.Patients with subarachnoid hemorrhage had a hunt and hess score ranging from i to iii.A total of 155 peds were used in the 139 aneurysms.The mean number of ped deployed for each aneurysm was 1.28 (range, 1-5).During the same procedure, adjunctive coiling was used for the treatment of 23 aneurysms.The main reason for the coils was to obtain prompt aneurysm thrombosis and occlusion.Citation: rangel-castilla l, cress m, munich s, et al.Feasibility, safety, and periprocedural complications of pipeline embolization for intracranial aneurysm treatment under conscious sedation.Operative neurosurgery 0:1-5, 2015.

Manufacturer Narrative

The lot history record review was not possible since the lot numbers were not reported.The devices will not be returned for analysis, therefore, the event cause could not be determined.There is limited information about the device and/or the patient, therefore all product problem events were captured in this report.Reference 2029214-2015-00815 for serious adverse events from the same article.

• Brand Name: PIPELINE 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: 4950903
• MDR Text Key: 6253328
• Report Number: 2029214-2015-00814
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 56 YR