MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR SOLITAIRE RD; CATHETER, THROMBUS RETRIEVER

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Death (1802); Occlusion (1984)

Event Date 06/05/2017

Event Type  Death  

Manufacturer Narrative

The solitaire devices have not been returned for evaluation.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 reported information.If information is provided in the future, a supplemental report will be issued.

Event Description

Dobrocky, t., piechowiak, e., cianfoni, a., zibold, f., roccatagliata, l., mosimann, p.,.Gralla, j.(2017).Thrombectomy of calcified emboli in stroke.Does histology of thrombi influence the effectiveness of thrombectomy? journal of neurointerventional surgery, 10(4), 345-350.Doi:10.1136/neurintsurg-2017-013226 medtronic literature review found reports of the following outcomes: patient #6 was treated for a left m2 occlusion with a solitaire 4x20.The baseline nihss was 24.The solitaire made 4 passes.The tici post the intervention was 0 and the mrs was 6 by the 3rd month.No complications.Patient #8 was treated for right carotid t occlusion.The baseline nihss was 16.A solitaire 6-30 made 3 pass and achieved tici of 1.There was note that the calcified clot was pushed into the m1 origin , which restored blood flow in the aca territory.Post the mechanical intervention, decompressive craniotomy was performed.The mrs was 6 by the 3rd month.

• Brand Name: SOLITAIRE RD
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 8265806
• MDR Text Key: 133686913
• Report Number: 2029214-2019-00045
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K113455
• 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: 01/21/2019

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/25/2018
• Initial Date FDA Received: 01/21/2019
• 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): Death; Other