MAUDE Adverse Event Report: ABBOTT VASCULAR EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

Model Number 22438-19

Device Problems Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2021

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a mildly calcified, heavily tortuous, 90% stenosed lesion in the left internal carotid artery.During retrieval of the emboshield nav6 embolic protection device (epd), while advancing the retrieval catheter, resistance was met with the 8f guiding catheter and the retrieval catheter could not be advanced or removed.The guiding catheter was used to retrieve the epd and successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Manufacturer Narrative

The device was returned for analysis.The reported difficult to advance was unable to be replicated in a testing environment as it was based on operational circumstances.The reported difficult to remove was unable to be confirmed.Additionally, multiple bends were noted on the device.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 identified no other similar incidents from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the 8f guiding catheter and/or interaction with the mildly calcified, heavily tortuous, 90% stenosed anatomy resulted in the reported difficult to advance and the reported difficult to remove.Manipulation of the device resulted in the noted multiple bends in the delivery catheter shaft and in the retrieval catheter shaft.The treatment appears to be related to the operational context of the procedure as the guiding catheter was used to retrieve the embolic protection device and successfully complete the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• Brand Name: EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
• Type of Device: EMBOLIC PROTECTION SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12833189
• MDR Text Key: 280933479
• Report Number: 2024168-2021-10530
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137754
• UDI-Public: 08717648137754
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 22438-19
• Device Catalogue Number: 22438-19
• Device Lot Number: 1012261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2021
• 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): Required Intervention