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

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 01/31/2014

Event Type  Death  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Dates estimated.The unique device identifier (udi) is unknown because the part and lot numbers was not provided.(b)(4).There was no device malfunction.The lot history record (lhr) could not be reviewed because the product was not returned for evaluation and the part and lot numbers were not reported.The reported patient effect of death, as listed in the emboshield nav6 instruction for use (ifu), is a known possible complication associated with carotid stents and embolic protection systems.It should be noted that per the ifu, the emboshield nav6 embolic protection system is indicated for use as a guide wire and embolic protection system to contain and remove embolic material while performing angioplasty and stenting procedures in carotid arteries.Based on the case information and related record review, a conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Emboshield nav6 embolic protection system for lower extremity indication.

Event Description

It was reported through a clinical study report identifying that the emboshield nav6 embolic protection device (epd) may be related to a patient death.One death was reported.Details are listed in the attached report, titled emboshield nav6 embolic protection system for lower extremity indication.Please see report for additional information.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 8511904
• MDR Text Key: 141891181
• Report Number: 2024168-2019-02903
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2019
• 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
• Patient Outcome(s): Death
• Patient Age: 83 YR