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

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

Patient Problems Intimal Dissection (1333); Hemorrhage, Cerebral (1889)

Event Date 10/11/2012

Event Type  Injury  

Event Description

Citation: cruz jp, o'kelly c, kelly m, et al.Pipeline embolization device in aneurysmal subarachnoid hemorrhage.Ajnr am j neuroradiol.2013 feb;34(2):271-6.Medtronic (covidien) received information from the literature cited that 3 procedure-related complications, 1 treatment failure, 4 post procedure complications occured during their study.Twenty patients (15 women; median age, 54.5 years; iqr, 8.0 years) with ruptured aneurysm as follows: 8 blister, 8 dissecting or dysplastic, 2 saccular, and 2 giant aneurysms were treated on average 4 days from rupture(range, 1-90 days; iqr, 12.75 days).Two technical complications: 1 direct carotid cavernous fistula after ped angioplasty, which resolved spontaneously, and 1 ica dissection seen 7 days later with ica occlusion and cortical infarcts.There was 1 treatment failure in a patient who underwent a first surgical clipping with significant residual aneurysm on postoperative angiography.A single ped was deployed, and despite initial acceptable placement, the aneurysm grew, requiring another intervention 8 days later, with 2 more overlapping peds.No hemorrhagic complications related to external ventricular drain removal occurred in this cohort.One patient required a ventriculoperitoneal shunt after the procedure and preoperative platelet transfusion, with no complications.There were 3 asymptomatic delayed complications, including 1 silent perforator infarct at 3-month follow-up mr imaging and 2 moderate in-stent stenoses.No symptomatic delayed complications or delayed rehemorrhages occurred.

Manufacturer Narrative

Aticle website: http://www.Ajnr.Org/content/34/2/271.Long.There is limited information about the device and/or the patient, therefore all serious adverse events were captured in this report.The lot history record review was not possible since the lot numbers were not reported.The devices will not be returned for analysis as they were implanted in the patient; therefore, the event cause could not be determined.Related mdr 2029214-2015-00397 for reportable death event 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 ; 9496801224
• MDR Report Key: 4704626
• MDR Text Key: 5721856
• Report Number: 2029214-2015-00396
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2015
• 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: 03/20/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 54 YR