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

Model Number UNK-NV-SFR

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

Patient Problems Intracranial Hemorrhage (1891); Insufficient Information (4580)

Event Date 07/20/2020

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

De castro afonso lh, borghini pazuello g, seizem nakiri g, et al.Thrombectomy for m2 occlusions and the role of the dominant branch. interventional neuroradiology: journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences.2019;25(6):697-704.Doi:10.1177/1591019919847693.Medtronic received a literature article in which the aim was to assess thrombectomy¿s efficacy and safety in patients with m2 segment occlusion and associations between occlusion sites and anatomic variations of m1 division.The mean national institutes health stroke scale score (nihss) upon hospital admission was 16.Among the 30 patients included in the study, 16 were men, and 14 were women.Mortality occurred in 9 patients.Among the nine patients who died from stroke before and up to the three-month follow-up, two patients who had serious intracranial hemorrhage died during their hospital stay, five died from sepsis (pneumonia), one from cardiac arrhythmia, and one because of massive intestinal bleeding.

• Brand Name: SOLITAIRE FR
• Type of Device: CATHETER, THROMBUS RETRIEVER
• 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: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 11402600
• MDR Text Key: 234390797
• Report Number: 2029214-2021-00232
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2021

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
• Device Model Number: UNK-NV-SFR
• Device Catalogue Number: UNK-NV-SFR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 03/02/2021
• 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
• Patient Age: 69 YR