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

Model Number	1011344-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Hypoxia (1918); Perforation of Vessels (2135)
Date of Event	06/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the heavily calcified and tortuous right common carotid artery.The procedure was performed placing an emboshield nav6 embolic protection device at the target site.Pre dilatation was performed using a viatrac dilatation catheter.An acculink stent delivery system was advanced over a non-abbott guide wire, and deployed without issue.As standard procedure, post dilatation was performed using a non-abbott dilatation catheter.There were no adverse patient effects or device issues noted during the procedure.Later, on the evening of the procedure, the patient experienced breathing difficulty and resuscitation was performed.It was noted that a hematoma had occurred and was obstructing the patient's airway.It was thought that the hematoma had formed over a perforation that had occurred during the procedure, but was not noted.The hematoma resolved on its own, with no additional intervention required.The patient condition resolved.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record could not be conducted because the lot number was not provided.The reported patient effects of hematoma and perforation are listed in the rx acculink carotid stent system instructions for use (ifu) as possible adverse events associated with 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.

• Brand Name: RX ACCULINK CAROTID STENT SYSTEM
• Common Device Name: 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: 15033964
• Report Number: 2024168-2022-07792
• Device Sequence Number: 15188225
• Product Code: NIM
• UDI-Device Identifier: 08717648076398
• UDI-Public: 08717648076398
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1011344-40
• Device Catalogue Number: 1011344-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EMBOSHIELD NAV6; TERUMO GLIDEWIRE GUIDE WIRE; VIATRAC DILATATION CATHETER
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Female