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

Catalog Number 22443-19

Device Problems Difficult to Remove (1528); Retraction Problem (1536); Deformation Due to Compressive Stress (2889)

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

Event Date 07/10/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat a moderately calcified, 100% stenosed lesion in the superficial femoral artery (sfa).During an atherectomy procedure, the emboshield nav6 embolic protection system (eps), was advanced to the target lesion and captured the debris without issue.During removal, the fully loaded nav6 filter could not be pulled back into the retrieval catheter, and the catheter became kinked.Another retrieval catheter was advanced in an attempt to remove the filter; however, the filter could not be pulled back into this retrieval catheter either.It was noted that it was possible the filter was loaded with too much debris, but was not confirmed.A sheath was then advanced and the nav6 filter was able to be pulled into the sheath and successfully removed from the anatomy.There were no reported adverse patient effects and no clinically significant delays in the procedure.No additional information was provided.

Manufacturer Narrative

B1: added adverse event.B2: added required intervention.H1: updated to serious injury.

Manufacturer Narrative

Visual and functional analysis was performed on the returned product.The reported retraction problem and difficult to remove could not be confirmed due to the condition of the returned unit, as the filtration element used during the procedure was not returned.The reported damage to the retrieval catheter was confirmed.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 complaints reported from this lot.Based on the reported event description and evaluation of the returned unit, the reported retraction problem, difficult to remove and kink, resulting in unexpected medical intervention appear to be due to circumstances of the procedure.It is likely that the filtration element was carrying an excessive embolic load resulting in resistance during the attempt to retract the filter into the retrieval catheter causing the retrieval catheter to kink.As a result, unexpected medical intervention was required to remove the filter with a sheath.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): 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: 17435284
• MDR Text Key: 320159647
• Report Number: 2024168-2023-08285
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22443-19
• Device Lot Number: 3031361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 08/01/2023
• Supplement Dates Manufacturer Received: 07/10/2023; 09/18/2023
• Supplement Dates FDA Received: 08/01/2023; 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2023
• 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
• Treatment: JETSTREAM
• Patient Outcome(s): Required Intervention