MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL REVIVE SE 4.5MM OUS; EMBOLECTOMY CATHETER

Catalog Number FRS21452299

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

Patient Problems Death (1802); Intracranial Hemorrhage (1891)

Event Date 05/31/2018

Event Type  Death  

Manufacturer Narrative

Product complaint # (b)(4).Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.  information regarding patient weight, height, medical history, race, and ethnicity was not reported.Cerenovus manufacturer's report numbers: 3008114965-2020-00146; 3008114965-2020-00147; 3011370111-2020-00032; 3008114965-2020-00148; 3011370111-2020-00033.Are related to the same incident.

Event Description

This complaint is from a literature source.As reported in the literature publication entitled, ¿a technical report on the performance of a new large bore cerebral aspiration catheter, the first results¿ 2 patients with acute ischemic stroke of the anterior circulation who underwent the endovascular procedure with stent retriever (combination group) experienced symptomatic intracranial hemorrhage died at 90-day follow-up.Objective: the initial results of the syphontrack super distal access (sda) catheter used for endovascular treatment of patients with acute ischemic stroke of the anterior circulation were described.Methods: a retrospective review of prospectively collected data from june 2017 to may 2018 with direct distal aspiration or a combination of distal aspiration with stent retriever thrombectomy was performed.

• Brand Name: REVIVE SE 4.5MM OUS
• Type of Device: EMBOLECTOMY CATHETER
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10006239
• MDR Text Key: 189215092
• Report Number: 3008114965-2020-00148
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• 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: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FRS21452299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2020
• Initial Date FDA Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 72 YR