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

Catalog Number 22443-19

Device Problems Difficult To Position (1467); Difficult to Remove (1528); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported that the procedure was to treat a lesion located in the proximal internal carotid artery that was moderately tortuous, mildly calcified and 70% stenosed.The sheath used in the procedure was a 6f x 90cm and was correctly positioned to release the protection system.During advancement of the emboshield nav6 embolic protection system, when the filter crossed the distal shaft of the sheath, it did not advance after about 1 cm exited the sheath.It was impossible to move the delivery system / filter (filter did not move forward or back) even with excessive force making the sheath fall from the carotid bulb.After discussion, in order to maintain the integrity of the patient and not risk any plaque or thrombus formation, it was decided to perform a maneuver by introducing an exchange guide 260 cm and remove the protection system along with the long sheath.The maneuver was successfully performed.A 7f x 11cm introducer was then introduced, requested a new long sheath, and a new filter was prepared according to technical protocol having guidance from the product specialist.After positioning the long sheath, a filter was advanced which crossed the lesion and it did release successfully.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual inspections were performed on the returned device.The reported resistance with the introducer sheath was not confirmed due to the condition of the returned device.The tear was confirmed.The investigation was unable to determine a cause for the reported difficulties.Reportedly, the separation occurred after the removal of the system from the patient.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Device analysis revealed the shaft was separated 6 mm proximal to the guide wire exit port and the outer member was torn 1.5 mm proximal to the proximal end of the separation for a length of 1 mm.Follow up confirmed the tear occurred inside the patient after the physician made several maneuvers, however, the separation occurred after the removal of the system from the patient.

• 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: 7567654
• MDR Text Key: 110028591
• Report Number: 2024168-2018-04135
• 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,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 22443-19
• Device Lot Number: 7082961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Date Manufacturer Received: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 49