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

Model Number 22438-19

Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that this was an atherectomy procedure in the right superficial femoral artery.The physician loaded the nav6 filter on to the non-abbott guide wire.The nav6 was inserted into the patient, but the filter basket detached from the delivery catheter when physician attempted to retrieve it.The emboshield nav6 filter basket came out of the delivery catheter when the physician was removing the barewire from the filter.He was able to retrieve the filter basket with the retrieval device.He used a 2nd nav6 to complete the procedure without further incident.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information provided.

Manufacturer Narrative

Visual analysis was performed on the returned device and noted a broken filter wire.The improper procedure and separation were unable to be 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 indication to suggest a lot specific product quality issue.The investigation determined that the reported failure to retrieve the filter was due to the circumstances of the procedure.The incident details stated,¿ the physician loaded the nav6 filter on to the non-abbott guide wire.¿ the barewire has a step that prevents the filter from embolism and enables the filter to be retrieved.The step or bump in the barewire for the emboshield is.019¿.The reported information indicated that the non-abbott wire was a viper 17.The viper 17 wire has a.017¿ step or bump.The filter stop id is.015¿.Additionally, the returned filter was found to have a broken wire.In this case, it is likely that the broken filter wire created enough resistive retrieval force that allowed the.017¿ bump of the viper wire to be pulled through the filter allowing its separation.The break in the filter was due to case circumstance.There is no indication of a product quality issue with respect to the design, manufacture, 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
• MDR Report Key: 11144309
• MDR Text Key: 226093080
• Report Number: 2024168-2021-00276
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137754
• UDI-Public: 08717648137754
• Combination Product (y/n): N
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 22438-19
• Device Catalogue Number: 22438-19
• Device Lot Number: 0081361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/10/2021
• Supplement Dates Manufacturer Received: 02/01/2021
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VIPER 17 GUIDE WIRE
• Patient Age: 59 YR