MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL THROMBECTOMY; EMBOLECTOMY CATHETER

Catalog Number UNKREVIVESE

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

Patient Problem Hemorrhage, Cerebral (1889)

Event Date 12/31/2015

Event Type  Injury  

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: 2954740-2020-00001, 2954740-2020-00002, 2954740-2020-00003, 2954740-2020-00005 are related to the same incident.

Event Description

This complaint is from a literature source.As reported in the literature publication entitled, ¿effect of balloon guide catheter utilization on contact aspiration thrombectomy¿ (pmid: 30497154).10 patients with acute ischemic stroke due to relevant intracranial internal carotid artery (ica) or middle cerebral artery (mca) m1 or proximal m2 segment occlusion who underwent contact aspiration thrombectomy (cat) experienced parenchymal hematoma type 1.Objective the role of the balloon guide catheter (bgc) has not been evaluated in contact aspiration thrombectomy (cat) for acute stroke.Here, the authors aimed to test whether the bgc was associated with recanalization success and good functional outcome in cat.Methods all patients who had undergone cat as the first line treatment for anterior circulation intracranial large vessel occlusion were retrospectively identified from prospectively maintained registries for six stroke centers.The patients were dichotomized into bgc utilization and nonutilization groups.Clinical findings, procedural details, and recanalization success rates were compared between the two groups.Whether the bgc was associated with recanalization success and functional outcome was assessed.Patient data were obtained from the prospectively maintained registries for six comprehensive stroke centers for the period between january 2011 and december 2015 cerenovus devices (revive distal access catheter) were used in this study.No devices specific information (including amount, catalog and lot number) were provided in the article.Concomitant products: penumbra reperfusion catheter, penumbra inc.; navien distal access catheter, medtronic neurovascular; shuttle, cook medical; neuronmax, penumbra inc; merci, stryker neurovascular; optimo, tokai medical; cello, medtronic neurovascular) cerenovus takes a conservative approach to report those events under cerenovus devices.

• Brand Name: THROMBECTOMY
• Type of Device: EMBOLECTOMY CATHETER
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; 821 fox lane; san jose CA 95131
• Manufacturer (Section G): MICRUS ENDOVASCULAR; 821 fox lane; san jose CA 95131
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9566635
• MDR Text Key: 188901117
• Report Number: 2954740-2020-00004
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 12/19/2019

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 Catalogue Number: UNKREVIVESE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/08/2020
• 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): Other
• Patient Age: 68 YR