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

Model Number UNK-NV-SOLITAIRE

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

Patient Problems Intracranial Hemorrhage (1891); Failure of Implant (1924)

Event Date 10/19/2023

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id unk-nv-solitaire (unknown); product type: ; implant date n/a; explant date n/a product id unk-nv-fg (unknown); product type: ; implant date n/a; explant date n/a product id unk-nv-fg (unknown); product type: ; implant date n/a; explant date n/a g2: citation: authors: biederko, r., honig, a., shabad, k., zlotnik, y., ben-arie, g., alguayn, f., shelef, i., <(>&<)> horev, a.Improved first-pass effect in acute stroke thrombectomy using solitaire-x compared to solitaire-fr.Frontiers in neurology 14:1215349 2023.Doi:10.3389/fneur.2023.1215349 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.See manufacturer report # 2029214-2023-02438 and 2029214-2023-02439 for other reports from this article.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.

Event Description

Biederko r, honig a, shabad k, et al.Improved first-pass effect in acute stroke thrombectomy using solitaire-x compared to solitaire-fr.Frontiers in neurology.2023;14:1215349.Doi:10.3389/fneur.2023.1215349 medtronic literature review found a report of patient complications in association with solitaire stent retriever and phenom microcatheter.The purpose of this article was to compare the procedural and clinical outcomes of solitaire fr to solitaire x.A total of 182 patients were included, with 91 procedures each using a solitaire fr or solitaire x.This included 111 males, and the mean age was 71.9 years old.It was noted that a phenom 21 microcatheter was used in some of the procedures, along with microcatheters from other manufacturers.The article does not state any technical issues during use of the  the following intra- or post-procedural outcomes were noted:  - the total 90-day-mortality was 32 patients (18 solitaire fr, 14 solitaire x). - in each solitaire group, there were seven patients who failed three attempts to recanalize with solitaire, and attempts were then made using other devices.Ultimately, rates of successful recanalization were similar between the two cohorts (90 solitaire fr, 88 solitaire x). - the solitaire-fr group had a double rate of post-procedural hemorrhagic transformation (27 solitaire fr, 14 solitaire x). - the mean number of repeated hospitalizations was.85 in the solitaire fr group, and.11 in the solitaire x group.

• 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: 18370279
• MDR Text Key: 331049077
• Report Number: 2029214-2023-02440
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• 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): Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male