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

Catalog Number 22443-19

Device Problems Difficult to Insert (1316); Product Quality Problem (1506); Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for investigation.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 de novo, 80% stenosed, mildly calcified lesion in the moderately tortuous mid carotid artery.There was slight resistance noted with the anatomy during advancement of the emboshield nav6 embolic protection system (eps).Reportedly, the filter was not difficult to deploy; however, the eps became deformed and would not retract completely into the retrieval catheter prior to removal.The eps had to be withdrawn almost 80% trapped and very cautiously.The procedure was completed using a non-abbott eps, a 5x20 mm viatrac balloon catheter and a 9x7x30 mm xact stent.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.

Event Description

New information: returned device analysis identified that the device had only been prepped and but did not appear to have been used.Follow up with the account confirmed that the correct device was returned and that there was a problem in loading the filter into the delivery catheter (dc) pod during preparation.After pulling it repeatedly with the help of torque device it became deformed.There was no patient involvement and the device was not used.No additional information was provided.

Manufacturer Narrative

Patient codes: 2645 labeled na.Device codes: 1316 labeled.Internal file number (b)(4).Corrections: device codes 1528 and 2920 were removed.Patient code 2199 was removed.Evaluation summary: visual, dimensional and functional inspections were performed.The reported difficult to insert and irregular appearance 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 identified no other similar incidents reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty to insert and irregular appearance.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: 8272666
• MDR Text Key: 133933952
• Report Number: 2024168-2019-00533
• 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: 06/11/2019

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: 07/31/2021
• Device Catalogue Number: 22443-19
• Device Lot Number: 8081661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019
• Initial Date Manufacturer Received: 01/02/2019
• Initial Date FDA Received: 01/23/2019
• Supplement Dates Manufacturer Received: 05/23/2019
• Supplement Dates FDA Received: 06/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1