MAUDE Adverse Event Report: AV-TEMECULA-CT EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

Catalog Number 22438-19

Device Problems Break (1069); Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical product: guide wire: amplatz.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a moderately calcified right subclavian artery that did not have tortuosity.A 190 cm emboshield nav6 embolic protection device (epd) was placed in the right internal carotid artery.However, a non-abbott guide wire that was in the subclavian artery damaged the tip of the epd filtration element.Therefore, the epd was removed without any issues and an unspecified stent was implanted in the right subclavian artery.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Device codes: 1506 not labeled.Internal file number - (b)(4).Correction: device code 1069 removed.The product was not returned to abbott vascular for analysis.Return of the embolic protection system may have further aided the analysis.A review of the electronic lot history record (elhr) and similar incident query for this product was not performed since the lot number was not reported and the product was not returned to abbott vascular for analysis.The investigation determined the reported difficulties appear to be related to operational circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
• Type of Device: EMBOLIC PROTECTION SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8341613
• MDR Text Key: 136267146
• Report Number: 2024168-2019-01127
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• PMA/PMN Number: K090665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22438-19
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE: AMPLATZ