MAUDE Adverse Event Report: AV-TEMECULA-CT RX ACCULINK CAROTID STENT SYSTEM

Catalog Number 1010128-40

Device Problems Mechanical Jam (2983); Activation Failure (3270); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Exemption number( b)(4) permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Evaluation summary: visual inspections were performed on the returned device.The reported deployment and thumbslide issue was unable to be confirmed due to the condition of the returned device.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the electronic complaint handling database revealed no other incidents reported from this lot.Based on the information reviewed, the reported deployment issue and resistance with the thumbslide was related to case circumstances.It is likely that the tear noted in the guide wire exit port influenced the deployment.The tear appears to be the result of the guide wire and shaft of the acculink being spread apart causing the guide wire to tear into the exit port.This likely occurred during position of the device prior to the deployment attempt.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was performed to treat a lesion in the internal carotid artery.A 7x40mm rx.014 acculink ii carotid self-expanding stent system was advanced to the target lesion; however, during deployment resistance with the thumbslide was felt and the stent could not be deployed.The procedure was successfully completed with an unspecified stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.The return device analysis identified that there was a tear in the guide wire exit port extending distally for a length of 2.2cm.The proximal end of the inner member was protruding out from the tear, for a length of 1.5cm.Additionally, the stent was partially deployed.

• Brand Name: RX ACCULINK CAROTID STENT SYSTEM
• Type of Device: CAROTID STENT 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: 8800856
• MDR Text Key: 151442084
• Report Number: 2024168-2019-05548
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• 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: 1010128-40
• Device Lot Number: 7121461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2017
• 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