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 Problems Stroke/CVA (1770); Intracranial Hemorrhage (1891); Vascular Dissection (3160); Embolism/Embolus (4438)

Event Date 06/01/2020

Event Type  Death  

Event Description

This complaint is from a literature source and the following citation was reviewed: xing pf, zhang yw, li zf, zhang l, shen hj, zhang yx, fang yb, zhao r, li q, huang qh, hong b, xu y, yang pf, liu jm.The ""distal-to-proximal"" strategy for the treatment of posterior circulation tandem occlusions: a single-centre experience.Neuroradiology.2020 jul;62(7):867-876.Doi: 10.1007/s00234-020-02412-0.Epub 2020 apr 3.Pmid: 32242265.Objective and methods: this article discusses the ""distal-to-proximal"" strategy (opening the distal occlusion first followed by treatment of the proximal pathology) as the center's preferred approach to treat posterior tandem occlusions (a special type of acute ischaemic stroke in the posterior circulation caused by large vessel occlusion (ais-lvo) that includes a proximal occlusion or severe stenosis s.A.Atherosclerotic stenosis or dissection and concomitant thromboembolism to the distal artery of the same territory).Primary endpoint of this review was a modified rankin scale (mrs) of 0-3 at 90 days follow-up.476 patients with ais-lvo who underwent endovascular treatment at the center were retrospectively analyzed.Only 21 patients (19 male, 2 female) with posterior circulation tandem occlusions were enrolled for analysis.Their mean age was 60 years old (range 32 to 80).In all of these patients, the distal lesions of the tandem occlusions were located at the tip of the basilar artery/ba (18 had vertebrobasilar artery tandem occlusion and 3 had basilar artery to basilar artery tandem occlusion).Different approaches on endovascular treatment were performed.14 patients were first treated with ba mechanical thrombectomy using path 1 (via unaffected vertebral artery/ va) or path 2 (via affected va).While the other 7 patients were first treated with balloon dilatation before ba thrombectomy (path 3) due to proximal severe stenosis restricting catheter passage or stent-retriever withdrawal.Multiple strategies for the treatment of proximal lesions after the distal lesions recanalization were also incorporated such as stent angioplasty, balloon dilatation angioplasty, iv tirofiban or no treatment, depending on the case.Only 19 patients were treated with iv tirofiban since the other 2 had good collateral compensation.Results showed all ba occlusions achieved good recanalization after mechanical thrombectomy.No re-occlusion from the ct angiography performed at 1 week in 16 cases.There was a reported good outcome on 12 patients with mrs of 0-3 while 11 patients had mrs of 0-2.There was a patient who had a reocclusion of the ba 6 months post-surgery (no stent implanted initially) then got treated with a non-cnv stent, however the occlussion still re-occurred.Lot, model and catalog number are not available, but the suspected cerenovus device possibly associated with reported adverse events: enterprise stent other cerenovus devices that were also used in this study: revive se stent retriever non-cerenovus devices that were also used in this study: stent-retrievers include solitaire ab, trevo provue (stryker); intermediate or aspiration catheters: navien (medtronic), ace (penumbra); stents: apollo balloon expandable stent (microport), rx acculink self-expanding stent (abbott), express balloon expandable stent (boston scientific), neuroform ez stent adverse event(s) and provided interventions: qty 2 - downstream territory embolism.One patient was listed in the article to have received the enterprise stent (case 4) and received tirofiban, however the other devices used for this case (catheter, stent retriever) were not mentioned.The other patient who had this event is case 18 and did not receive any stent nor tirofiban.No patient outcome included.No treatment/intervention mentioned.Qty 1 - symptomatic intracranial hemorrhage (case 5).A non-cnv stent was implanted in this patient.Tirofiban was given to this patient.No patient outcome, administered treatment, intervention listed.Qty 2 - vessel dissection which was noted to be procedure-related (cases 7 & 16).Both patients received tirofiban and had non-cnv stents implanted.No information on patient outcome, administered treatment, intervention provided.Qty 4 - stroke within 90 days.These patients were noted to have died because of this event.It was not specified in the article who are these patients/case numbers.No information provided on what treatment and/or intervention was provided to these patients between the stroke event and their death.

Manufacturer Narrative

Product complaint #
=
> (b)(4).This complaint is from a literature source and the following citation was reviewed: xing pf, zhang yw, li zf, zhang l, shen hj, zhang yx, fang yb, zhao r, li q, huang qh, hong b, xu y, yang pf, liu jm.The ""distal-to-proximal"" strategy for the treatment of posterior circulation tandem occlusions: a single-centre experience.Neuroradiology.2020 jul;62(7):867-876.Doi: 10.1007/s00234-020-02412-0.Epub 2020 apr 3.Pmid: 32242265.The dates of death are not available.Due to the nature of the complaint, the device (s) were not returned for analysis nor was the sterile lot numbers provided in order to conduct a lot history review.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Embolism and death are listed as potential adverse event associated with the use of the enterprise stent per its instructions for use (ifu).There was no mention of a device malfunction or performance issue mentioned for the subject who was implanted with this device.It is not clear from the literature if the embolism that occurred in this patient was related to any of the patients who suffered stroke and died, however the relationship between the embolism and the enterprise stent cannot be excluded.Therefore, this event with enterprise stent is considered as serious and mdr reportable.The file will be re-reviewed if additional information is received at a later date.

Manufacturer Narrative

Product complaint#: (b)(4).Section b5: additional information was received on 27-oct-2022.Summary of additional information provided: in cases: (b)(6) revive se stents were used, but the product information was unobtainable.The event date was unobtainable.For cases: (b)(6), jnj-related devices were not used.The case numbers of the 4 patients who suffered strokes and died were unobtainable.The dates of death and stroke onset for each of these patients were also unobtainable.The patient outcomes, the provided treatment, and/or intervention for these adverse events were unobtainable.The physician considers that the causality of these adverse events is not related to the jnj device (s).None of the events reported resulted in an in-patient hospitalization/prolonged hospitalization.There was no evidence of a device malfunction or performance issues on the enterprise stent, revise se stent retriever/s.The information regarding the other devices used was unobtainable.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: THROMBECTOMY
• 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): MICRUS ENDOVASCULAR; 821 fox lane; san jose CA 95131
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15633511
• MDR Text Key: 302018274
• Report Number: 3008114965-2022-00675
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• 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,Followup
• Report Date: 11/01/2022

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: 09/29/2022
• Initial Date FDA Received: 10/19/2022
• Supplement Dates Manufacturer Received: 10/27/2022
• Supplement Dates FDA Received: 11/01/2022
• 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: Initial
• Patient Sequence Number: 1
• Treatment: ACE (PENUMBRA).; APOLLO BALLOON EXPANDABLE STENT (MICROPORT).; EXPRESS BALLOON EXP STENT (BOSTON SCIENTIFIC).; INTERMEDIATE OR ASPIRATION CATHETERS.; NAVIEN (MEDTRONIC).; NEUROFORM EZ STENT.; REVIVE SE STENT RETRIEVER.; RX ACCULINK SELF-EXPANDING STENT (ABBOTT).; STENT-RETRIEVERS INCLUDE SOLITAIRE AB.; STENTS.; TREVO PROVUE (STRYKER).
• Patient Outcome(s): Death