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

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

Patient Problem Insufficient Information (4580)

Event Date 04/01/2020

Event Type  Death  

Manufacturer Narrative

Ho jun yi, jae hoon sung, dong hoon lee, seung yoon song.Effectiveness and technical considerations of solitaire platinum 4x40 mm stent retriever in mechanical thrombectomy with solumbra technique.Journal of korean neurosurgical society.2021;64(1):30-38.Doi:10.3340/jkns.2020.0046.Age or date of birth: this value is the average age of the patients reported in the article as specific patients could not be identified.Sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Date of event: please note that this date is based off of the date of publication of the article [or the date that the article was accepted for publication] as the event dates were not provided in the published literature.If information is provided in the future, a supplemental report will be issued.

Event Description

Ho jun yi, jae hoon sung, dong hoon lee, seung yoon song.Effectiveness and technical considerations of solitaire platinum 4x40 mm stent retriever in mechanical thrombectomy with solumbra technique.Journal of korean neurosurgical society.2021;64(1):30-38.Doi:10.3340/jkns.2020.0046.Medtronic literature review found reported of patient complications in association with solitaire thrombectomy.The purpose of this article was evaluate the effect of solitaire platinum 4×40 mm stent retriever in solumbra technique thrombectomy (stent retriever with simultaneous aspiration), and compare it with shorter solitaire stent retrievers with equal diameter (4 mm) and different length (40 vs.20 mm) solitaire stent retrievers: the solitaire platinum 4×40 mm stent (4×40) and the solitaire fr 4×20 mm stent or solitaire platinum 4×20 mm stent.The authors reviewed 70 cases of patients who underwent solumbra technique thrombectomy.Of the 70 patients, the average age was 70 years, 29 were female and 41 were male.The article does not state any technical issues during use of the solitaire.The following intra- or post-procedural outcomes were noted for the 4x40 solitaire: the 3 month mortality included 2 patients.

• 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: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 11396580
• MDR Text Key: 234200311
• Report Number: 2029214-2021-00220
• 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,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• 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
• Date Manufacturer Received: 02/06/2021
• 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
• Patient Age: 70 YR