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

Device Problem Activation Failure (3270)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  malfunction  

Manufacturer Narrative

Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure and post procedure related event.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.The reported adverse events are known inherent risk of endovascular procedure and are documented in our device¿s instruction for use (ifu).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic receive the following report through literature review of ¿pipeline embolization device for the treatment of intracranial pseudoaneurysms¿ (stephanie h.Chen, david j.Mccarthy, dallas sheinberg, ricardo hanel, samir sur, pascal jabbour, elias atallah, nohra chalouhi) a total of 19 patients with a mean age of 50 years (range, 16-74 years) underwent ped placement for intracranial psa.Of the 18 patients with follow-up imaging, 14 achieved complete pseudoaneurysm obliteration.Of these, 1 patient had an additional ped deployed 1 week after the initial procedure.Two patients subsequently underwent sacrifice of the parent ica because of persistent filling and progression of the psa on short-term follow up within 1 month.No patients experienced new neurologic deficits or deterioration secondary to ped placement.Adequate documentation of the modified rankin scale score at last follow-up was available for 11 patients; 10 patients had a modified rankin scale score of 2 or less, indicative of a favorable outcome.One death occurred during follow-up, unrelated to the pseudoaneurysm or ped placement, resulting from progression of systemic melanoma.No patients experienced bleeding events after treatment with the ped for psa.Illustrative case 3: a (b)(6)-year-old patient presented with headaches and visual changes and was diagnosed with a pituitary macroadenoma.During endoscopic transsphenoidal resection, brisk arterial bleeding was encountered and continued despite packing and inflation of a fogarty balloon within the resection cavity.Blood pressure dropped to 40/20 mm hg, and massive transfusion protocol was initiated with subsequent emergent transfer to angiography suite.The cerebral angiogram demonstrated a focal injury to the cavernous ica.A 5-mm-diameter ped was deployed across the site of injury despite angiographic measurement of a smaller diameter ica.Angiography 36 hours later showed poor wall apposition of the ped and active extravasation with persistent filling of the pseudoaneurysm.Parent vessel occlusion of the ica using coils and liquid embolic agents was undertaken after confirming angiographic criteria was met for passing a balloon test occlusion.The patient recovered well and was discharged neurologically intact but was lost to follow-up.

• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 8778684
• MDR Text Key: 153119286
• Report Number: 2029214-2019-00721
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: Yes
• 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: 06/13/2019
• Was Device Evaluated by Manufacturer?: No
• 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