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

Catalog Number	1011344-40
Health Effect - Clinical Codes	Seizures (2063); Thrombosis (2100)
Date of Event	02/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.The reported patient effects of seizures and thrombosis are listed in the rx acculink instruction for use as known patient effects.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.The viatrac device is being filed under separate medwatch report.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the internal carotid artery.On (b)(6) 2018, a 4x20x135mm viatrac plus balloon catheter was being used for pre-dilatation; however, the balloon ruptured during first inflation at 4 atmospheres.A 7-10x40mm acculink stent was implanted and the procedure was completed successfully with the patient being given plavix post-procedure.The patient had a seizure overnight and a computerized tomographic angiography confirmed thrombosis in the acculink stent.The patient is in stable condition and is going back to the cath lab on (b)(6) 2018 to have a covered stent implanted to treat the thrombosis.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: RX ACCULINK CAROTID STENT SYSTEM
• Common Device Name: CAROTID STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7265234
• Report Number: 2024168-2018-01026
• Device Sequence Number: 1475135
• Product Code: NIM
• UDI-Device Identifier: 08717648076398
• UDI-Public: 08717648076398
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P040012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2018

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 Expiration Date: 11/30/2018
• Device Catalogue Number: 1011344-40
• Device Lot Number: 6120861
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 02/12/2018
• Supplement Report FDA Received Date: 04/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention