MAUDE Adverse Event Report: ABBOTT VASCULAR RX ACCULINK CAROTID STENT SYSTEM

Model Number 1011344-30

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); Nervous System Injury (2689)

Event Date 12/15/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of occlusion is listed in the rx acculink carotid stent system instructions for use as a possible adverse event associated with the use of this device.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

Event Description

It was reported that the procedure was to treat a heavily tortuous, heavily calcified right external common carotid artery.On (b)(6) 2021, an acculink stent was successfully deployed.The next day, on (b)(6) 2021, the patient showed signs of hyperperfusion (unknown if blood pressure was too high or too low).The patient's blood pressure was medically managed (patient remained under observation but condition remained relatively stable and no treatment was performed).Then on (b)(6) 2021, imaging and ultra sound showed 70% occlusion.The surgeon decided to surgically remove the stent and treat the occlusion via a carotid surgical endarterectomy intervention.Hospitalization was prolonged but patient condition was fine after surgical procedure.No additional information was provided.

• Brand Name: RX ACCULINK CAROTID STENT SYSTEM
• Type of Device: CAROTID STENT
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13172188
• MDR Text Key: 285495397
• Report Number: 2024168-2022-00111
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648076381
• UDI-Public: 08717648076381
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 1011344-30
• Device Catalogue Number: 1011344-30
• Device Lot Number: 1052561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 88 KG