MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE SUPRA CORE 35 GUIDE WIRE WITH MICROGLIDE COATING

Catalog Number UNK HT SUPRA CORE 35

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

Patient Problems Bradycardia (1751); Stroke/CVA (1770); Death (1802); Embolus (1830); Low Blood Pressure/ Hypotension (1914); Thrombus (2101)

Event Date 01/01/2014

Event Type  Death  

Manufacturer Narrative

Pt age: average age.Pt gender: majority gender.Event date: estimated date.The udi is reported as unknown since the part and lot numbers were not provided.Product performance engineering reviewed the incident information; however, there was no reported device malfunction and the product was not returned.A review of the lot history record for this product was not performed since the part and lot numbers were not reported.A conclusive cause for the reported death and the relationship to the product, if any, cannot be determined.Based on the article and case information, a conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined.Additionally, treatments appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional patient effects and viatrac device, referenced are being filed under separate medwatch report numbers.Article attachment: impact of plaque dilation before carotid artery stent deployment.

Event Description

It was reported through a research article that the hi-torque supra core superstiff guidewire and the viatrac dilatation balloon catheter may be related to macroscopic debris, embolus, major and minor stroke, thrombus, thrombolytic treatment, hemodynamic depression including hypotension and bradycardia, and death.Specific patient information is documented as unknown.Details provided in the article titled: "impact of plaque dilation before carotid artery stent deployment.

• Brand Name: HI-TORQUE SUPRA CORE 35 GUIDE WIRE WITH MICROGLIDE COATING
• Type of Device: GUIDE WIRE
• 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: 11380707
• MDR Text Key: 233691766
• Report Number: 2024168-2021-01482
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K980119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HT SUPRA CORE 35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death
• Patient Age: 75 YR