MAUDE Adverse Event Report: AV-TEMECULA-CT RX ACCUNET EMBOLIC PROTECTION SYSTEM

Catalog Number 1011649-55

Device Problems Retraction Problem (1536); Material Separation (1562)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 03/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a lesion in the internal and common carotid artery.A rx accunet embolic protection system (eps) was advanced.A 7-10x40mm.014 acculink ii rx stent was advanced to the target lesion and the stent was deployed without issues.An attempt was made to retrieve the eps filter with one of the retrieval catheter provided per the instructions for use; however, the filter would not fully engage with the retrieval catheter.It was then decided to attempt to use the second retrieval catheter provided in the 3-in-1 rx accunet eps.An attempt to remove the first retrieval catheter was made; however, since the filter was partially engaged with the retrieval catheter the filter separated from the wire and landed at the proximal end of the deployed acculink stent.Balloon angioplasty was performed a couple of times to facilitate filter movement and a 7x20mm.014 acculink ii rx stent was deployed to appose the filter against the vessel wall.The patient is fine and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: visual inspections were performed on the returned device.The reported separation was confirmed.The difficulty removing (recovering the filter) could not be tested as the filter was not returned.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 similar incidents.The investigation was unable to determine a definitive cause for the reported difficulties.It may be possible that the filter was over-loaded with emboli such that the filter was unable to collapse into the recovery catheter, and when force was applied, the filter detached from the wire.However, this could not be confirmed.The additional treatment to appose the detached filter against the vessel wall was related to case circumstances.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: RX ACCUNET 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: 8528593
• MDR Text Key: 142393287
• Report Number: 2024168-2019-03071
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 1011649-55
• Device Lot Number: 9020761
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/09/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2019
• 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: STENT: .014 ACCULINK II 7-10X40MM
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR