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

Catalog Number 22438-19

Device Problems Difficult to Insert (1316); Kinked (1339); Improper or Incorrect Procedure or Method (2017); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2017

Event Type  malfunction  

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 relevant information.

Event Description

It was reported that the patient underwent a peripheral procedure to treat a target lesion in the heavily calcified and heavily tortuous popliteal artery.The emboshield nav6 embolic protection device was advanced to the target site and deployed without difficulty.After use, the emboshield retrieval catheter was advanced with difficulty to the filter and the shaft kinked.The filter was noted to be about 70% full.Because the filter was full of debris and the anatomy was tortuous, the filter could not be pulled into the retrieval catheter.The filter, retrieval catheter and guide wire were removed from the anatomy as a single unit without difficulty.There was no reported adverse patient sequela or a clinically significant delay in procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual and functional inspections were performed on the returned device.The reported difficulty retrieving the filter was not able to be confirmed due to the condition of the returned device.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 revealed no other similar incidents.The emboshield nav6 embolic protection system electronic instructions for use states: the system is indicated for use during percutaneous transluminal angioplasty and stenting procedures in saphenous vein grafts and carotid arteries.The reported difficulties appear to be due to a large embolic load and there is no indication that the off-label use caused or contributed to the difficulties.The investigation determined that the reported difficulties are due to case circumstances and 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
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6790359
• MDR Text Key: 82661319
• Report Number: 2024168-2017-06647
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K090665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 22438-19
• Device Lot Number: 6122161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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 Age: 73 YR
• Patient Weight: 74