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

Model Number UNK-NV-SOLITAIRE

Device Problems Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Ischemia Stroke (4418)

Event Date 09/27/2022

Event Type  Death  

Event Description

Kim jh, choi j-i.Feasibility of rescue stenting technique in patients with acute ischemic stroke due to middle cerebral artery occlusion after failed thrombectomy: a single-center retrospective experience.Plos one.2022;17(9):e0274842.Doi:10.1371/journal.Pone.0274842 medtronic literature review found a report of death and intracranial hemorrhage in association with solitaire thrombectomy.The purpose of this article was to compare the efficacy and outcomes of rescue stents used in patient's that underwent a failed mechanical thrombectomy compared to patients that had a successful mechanical thrombectomy.The authors reviewed 243 cases of patients treated for ischemic strokes using solitaire mechanical thrombectomy.Of the 243 patients, the average age was 67 years, 23 were female and 220 were male.Of the 243 cases, 183 patients had a middle cerebral artery occlusion alone, 53 patients had failed to see thrombolysis after their mechanical thrombectomy which resulted in a tici score of 2a or worse.Of the 53 patients that had a failed thrombectomy, 31 patients received a mechanical thrombectomy without stenting, and 22 patients had a rescue stent deployed.Patients in the rescue stent group showed higher recanalization and good mrs score at 3 months compared to the patients who did not received a rescue stent but had a failed mechanical thrombectomy.The article does state the solitaire fr failed in 53 cases and a rescue stent was placed in 22 patients.In addition, at the 3 month follow up 16 patients of the 53 failed mechanical thrombectomies had a good mrs score (0-2) and 31 had a poor mrs score.The following intra- or post-procedural outcomes were noted: death (3) intracranial hemorrhage (5).

Manufacturer Narrative

Continuation of d10: product id unk-nv-cello (unknown); product type: ; implant date n/a; explant date n/a product id unk-nv-solitaire (unknown); product type: ; implant date n/a; explant date n/a product id unk-nv-cello (unknown); product type: ; implant date n/a; explant date n/a g2: citation: authors: kim jh, choi j-i.Feasibility of rescue stenting technique in patients with acute ischemic stroke due to middle cerebral artery occlusion after failed thrombectomy: a single-center retrospective experience.Plos one.17(9):e0274842.2022.Doi:10.1371/journal.Pone.0274842 earliest date of publication used for date of event no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN SOLITAIRE
• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 18388039
• MDR Text Key: 331283224
• Report Number: 2029214-2023-02460
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-SOLITAIRE
• Device Catalogue Number: UNK-NV-SOLITAIRE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2023
• 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
• Treatment: SEE H10...
• Patient Outcome(s): Death