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

Catalog Number 22437-19

Device Problems Retraction Problem (1536); Difficult or Delayed Activation (2577); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the stent was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a lesion located in the mid common carotid artery that was heavily tortuous, heavily calcified and 93% stenosed.Due to vessel tortuosity, the filter was difficult to deploy and once deployed, the filter migrated proximally, settling close to the lesion.With some manipulation, the lesion was successfully treated.Resistance was noted during filter removal, but the filter was successfully retrieved with the retrieval catheter and removed from the anatomy, without issue.The intervention was noted to be successful.There was no additional information provided.

Manufacturer Narrative

Internal file number: (b)(4).The product was not returned to abbott vascular for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history revealed no other similar incidents reported for this lot.The investigation determined the reported difficulty to deploy, difficulty to remove and migration of the device or device component appear to be related to operational circumstances of the procedure.Based on the reported information, it is likely that the heavily tortuous, heavily calcified and 93% stenosed anatomy resulted in the difficulty to deploy the filter.Manipulation of the eps against resistance likely caused the filter to migrate further from the intended location.The reported resistance or difficulty to remove the filter was likely caused by a large load on the filter during removal.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: 8638400
• MDR Text Key: 146056145
• Report Number: 2024168-2019-04089
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 22437-19
• Device Lot Number: 8010462
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 65