MAUDE Adverse Event Report: AV-TEMECULA-CT RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER

Catalog Number 1008193-20

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Thrombosis (2100); Prolapse (2475)

Event Date 06/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The customer reported the device was discarded.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 to treat the mid common carotid artery that did not have any tortuosity.A 190 cm emboshield nav6 embolic protection device (epd) was positioned, and pre-dilatation was performed with a 3.0 x 20 mm nc trek balloon catheter.A non-abbott stent was then implanted, and post-dilatation was performed with a 5.0 x 20 mm viatrac balloon catheter.A neurological test was done, and it was noted that the stent was occluded with thrombus or soft plaque, and there was an issue with the non-abbott stent reducing flow.The epd had captured embolis and was blocked.Therefore, the epd was aspirated and removed.The non-abbott stent was still reducing flow.A 30 x 9-7 mm xact stent was then implanted inside the non-abbott stent for support, and standard post-dilatation was performed with a 4.0 x 20 mm viatrac balloon catheter.Another neurological test was done and the occlusion was still noted.It was not possible to aspirate as the occlusion was too distal; therefore, the patient was sent to the intensive care unit (icu) and anticoagulation was performed.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).The device was not returned for evaluation.It should be noted that the viatrac plus instruction for use (ifu), states: the viatrac 14 plus peripheral dilatation catheter is intended for use to dilate stenosis in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries).The reported patient effect of thrombus is listed in the ifu, as a known potential patient effect associated with the use of the device.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 and related record review, 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.

• Brand Name: RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8761357
• MDR Text Key: 150118838
• Report Number: 2024168-2019-05411
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K102705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 1008193-20
• Device Lot Number: 9030661
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STENT: DIVERSE DEVICES, FILTER: NAV6 190CM
• Patient Outcome(s): Hospitalization; Required Intervention