MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REFLEX CATHETER; CATHETER, PERCUTANEOUS

Model Number UNK-NV-RFX

Device Problem Material Perforation (2205)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Daniel a tonetti, shashvat m desai, stephanie casillo, benjamin m zussman, ashutosh jadhav, brian thomas jankowitz, tudor g jovin, bradley a gross.Stentriever salvage after failed manual aspiration thrombectomy.Doi:10.1136/neurintsurg-2019-014828 medtronic literature review found a report of patient complications after during the use of the navien catheter.The purpose of the study was to identify predictors of successful crossover to smat (stent retriever mediated aspiration thrombectomy) after failed first pass mat (manual aspiration thrombectomy).Of 433 patients undergoing large vessel intracranial thrombectomy during the study period, 319 consecutive patients underwent first pass mat for lvo.Mean age was 71.4 years and 52.4% were women.One of six aspiration catheters were used for the initial clot in this study: the ace 60, 64, or 68 reperfusion catheter (penumbra inc), the sofia plus (microvention, aliso viejo, california, usa), axs catalyst 6 distal access catheter (stryker neurovascular), and the 6 f 0.072 inch navien intracranial support catheter (medtronic, irvine, california, usa).It is unclear whether the 18 complications reported were involved with the manufacturer's device.- there were 13 instances of vessel perforation; two of these occurred in patients who underwent smat, yielding an overall 3% rate of perforation for those patients undergoing smat and a 4% rate for those with mat only (p=1).

• Brand Name: REFLEX CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9484126
• MDR Text Key: 209174945
• Report Number: 2029214-2019-01256
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-NV-RFX
• Device Catalogue Number: UNK-NV-RFX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2019
• 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