MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number NV UNK PIPELINE

Device Problem Activation Failure (3270)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/16/2021

Event Type  malfunction  

Event Description

Gündogmus, c.A., sabet, s., baltacioglu, n.A., türeli, d., bayri, y., & amp; baltacioglu, f.(2021).Long-term results and comparison of flow re-direction endoluminal device and pipeline embolization device in endovascular treatment of intracranial carotid aneurysms.Interventional neuroradiology, 159101992110307.Https://doi.Org/10.1177/15910199211030780 summary: internal carotid artery (ica) aneurysms constitute 30% of all intracranial aneurysms and are ever more frequently diagnosed thanks to the ubiquitous use of magnetic resonance imaging.Due to these inherently large and wide-necked aneurysms, endovascular treatment of ica aneurysms is exceptionally troublesome and has high recurrence rates even with stent-assisted coil embolization techniques.Identified events: device deployment failure in two embolization devices.One of the pipeline devices that failed to deploy was due to the pipeline not expanding and was being treated for a cervical loop.The patient was treated with adequate ipsilateral flow from the contralateral ica and posterior circulation.The patient recovered from anesthesia without any neurologic sequela.The aneurysm was occluded along with the parent artery.One patient presented with subarachnoid hemorrhage due to rupture of index aneurysm on the 10th -day after flow diversion with ped.Dsa revealed the distal end of the stent migrated proximally and re-diverted flow into the aneurysm sac and led to bleeding.However, this also remodeled the aneurysm neck, allowing the coiling of the aneurysm while maintaining ica patency.The patient was discharged without sequelae additional event information: pipeline embolization device (ped; ev3 neurovascular, irvine, ca).Fifty-four patients (39.1%) were diagnosed incidentally, whereas 49 patients (35.5%) presented with headache, 11 patients (8%) with subarachnoid hemorrhage due to ruptured index aneurysm, one patient (0.7%) with subarachnoid hemorrhage originating from a different aneurysm, 14 patients (10.1%) with cranial nerve dysfunction, and nine patients (6.5%) with neurologic deficits such as hemiparesis and paresthesia.In 19 patients, one flow diverter was used to treat two aneurysms; in two patients, one device was used to treat three aneurysms; and one patient had six adjacent aneurysms covered using a single device.In addition, one patient who was initially treated with ped required two additional peds to be deployed telescopically due to early spontaneous rupture of the treated aneurysm.In another patient, treatment of a bleeding blister aneurysm called for the deployment of three ped devices telescopically during the same session.Additional coiling was used in treatment of 17 patients.

Manufacturer Narrative

Gündogmus, c.A., sabet, s., baltacioglu, n.A., türeli, d., bayri, y., & amp; baltacioglu, f.(2021).Long-term results and comparison of flow re-direction endoluminal device and pipeline embolization device in endovascular treatment of intracranial carotid aneurysms.Interventional neuroradiology, 159101992110307.Https://doi.Org/10.1177/15910199211030780.This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Please note that this date is based off of the date that the article was accepted for publication as the event dates were not p rovided in the published literature.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events associated regulatory report: 2029214-2022-00304.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE
• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13602697
• MDR Text Key: 286578738
• Report Number: 2029214-2022-00305
• 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,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: NV UNK PIPELINE
• Device Catalogue Number: NV UNK PIPELINE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/25/2022
• 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
• Patient Sex: Female