MAUDE Adverse Event Report: ABBOTT VASCULAR 0.014 HI-TORQUE (HT) TURNTRAC GUIDE WIRE

Model Number 1020013

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problems Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Foreign Body In Patient (2687)

Event Date 10/14/2022

Event Type  Death  

Event Description

It was reported that the procedure was to treat the heavily calcified, heavily tortuous, 70% stenosed left anterior descending (lad) coronary artery.The turntrac guide wire was being removed after stenting in the posterior descending and right coronary arteries (rca) and the distal portion separated and remained in the rca.There was resistance with the stent noted during removal of the turntrac guide wire after stent implant.The coils were lost and could not be retrieved.After a while the flow of the rca became slow and the patient became unstable due to a drop in blood pressure.Cardiopulmonary resuscitation (cpr) was performed and the patient was transferred to a different hospital.The patient expired 5-6 days later.No additional information was provided.

Manufacturer Narrative

Date of death estimated.The device was returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

Subsequent to the previously filed report, it was reported that the xience stent was implanted without issue and there were no adverse patient effects due to the xience stent.No additional information was provided.

Manufacturer Narrative

A visual and dimensional inspection were performed on the returned device.The reported material separation was confirmed.The reported difficult to remove could not be tested as it was based on operational context.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties and patient effects; however, the subsequent treatments appear to be related to the operational context of the procedure.Factors that may contribute to difficulty removing the guide wire from the anatomy include, but are not limited to, patient¿s disease state, patient¿s anatomical morphology outer diameter of the guide wire, and/or damage to the guide wire.Factors that may contribute to material separation include, but are not limited to, tensile strength, corrosion, excessive force applied to device, interaction with accessory devices, and/or interaction with challenging anatomy.Based on the information provided it is unknown what may have caused or contributed to the reported difficulty removing the guide wire.Additionally, due to the stretched coils and bent core noted during return analysis, it is possible that manipulation of the guide wire when attempting to remove it from the anatomy, may have contributed to the noted damages, and reported material separation; however, this cannot be confirmed.The separated portion of the guide wire was unable to be retrieved from the anatomy.It cannot be definitively stated that the turntrac wire was the direct cause of the patient¿s death.Though it is possible that it was an indirect cause of the patient¿s death.There is no indication of a product quality issue with respect to manufacture, design, or labeling.The procedure description was updated.Date received by mfg- updated from 12/2/2022 to 12/5/2022, the date the new information was provided.Additional mfg narrative was updated.

Event Description

Subsequent to the initially filed report, it was reported that the rca and posterior descending arteries (pda) had diffuse disease with 20% calcification, 20% tortuosity.The rca was stented with a xience stent and the turntrac guide wire was used as a second wire.No additional information was provided.

Manufacturer Narrative

A visual and dimensional inspection were performed on the returned device.The reported material separation was confirmed.The reported difficult to remove could not be tested as it was based on operational context.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties and patient effects; however, the subsequent treatments appear to be related to the operational context of the procedure.Based on the information provided it is unknown what may have caused or contributed to the reported difficulty removing the guide wire.Additionally, due to the stretched coils and bent core noted during return analysis, it is possible that manipulation of the guide wire when attempting to remove it from the anatomy may have contributed to the noted damages, and reported material separation; however, this cannot be confirmed.The separated portion of the guide wire was unable to be retrieved from the anatomy.It cannot be definitively stated that the turntrac wire was the direct cause of the patient¿s death.Though it is possible that it was an indirect cause of the patient¿s death.There is no indication of a product quality issue with respect to manufacture, design, or labeling.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer stated: ¿it was reported that this was a case to treat a heavily calcified, heavily tortuous, 70% stenosed left anterior descending (lad) coronary artery.The report does not mention the original condition of the right coronary artery (rca).It was reported that the turntrac wire met resistance during the wire removal from the posterior descending artery (pda) after it was stented.It is mentioned that the rca was also stented.The report, however, does not mention where the rca stent was placed, if the turntrac was used as a buddy wire in the pda, or if the rca stent was deployed while the turntrac wire was in the pda.It was reported that no force was used during the wire removal and that the coils of the turntrac wire came off the distal end and were lost in the rca, and no retrieval attempts were made.The condition of the wire within the pda was not reported, so the cause cannot be stated how the coils became separated from the distal portion of the wire.The lost coils did embolize in the distal rca, causing the blood flow to slow, which eventually caused the patient¿s blood pressure to drop.The patient became hemodynamically unstable, cardiopulmonary resuscitation was initiated, and the patient was eventually transferred to another hospital for further care.It was reported that the patient expired 5-6 days post-procedure.The cause of death was unreported.Due to the lack of information provided, it cannot be definitively stated that the turntrac wire was the direct cause of the patient¿s death.Though it is possible that it was an indirect cause of the patient¿s death.¿b5: procedure description was updated.

Manufacturer Narrative

A visual and dimensional inspection were performed on the returned device.The reported material separation was confirmed.The reported difficult to remove could not be tested as it was based on operational context.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties and patient effects; however, the subsequent treatments appear to be related to the operational context of the procedure.Factors that may contribute to difficulty removing the guide wire from the anatomy include, but are not limited to, patient¿s disease state, patient¿s anatomical morphology, interaction with an accessory device, and/or damage to the guide wire.Factors that may contribute to material separation include, but are not limited to, tensile strength, corrosion, excessive force applied to device, interaction with accessory devices, and/or interaction with challenging anatomy.In this case, it is possible that an interaction between the guide wire and deployed stent may have contributed to the reported difficult to remove.Additionally, manipulation of the guide wire during its interaction with the stent may have contributed to the noted damages, and reported material separation; however, this cannot be confirmed.The separated portion of the guide wire was unable to be retrieved from the anatomy.It cannot be definitively stated that the turntrac wire was the direct cause of the patient¿s death; however, it is possible that it was an indirect cause of the patient¿s death.The reported patient effect of hypotension is listed in the hi-torque turntrac guide wire instructions for use as a potential adverse event associated with the use of this device.There is no indication of a product quality issue with respect to manufacture, design, or labeling.This case was reviewed by an abbott vascular medical reviewer.The reviewer stated: ¿it was reported that this was a case to treat a heavily calcified, heavily tortuous, 70% stenosed left anterior descending (lad) coronary artery.The report does not mention the original condition of the right coronary artery (rca).It was reported that the turntrac wire met resistance during the wire removal from the posterior descending artery (pda) after it was stented.It is mentioned that the rca was also stented.The report, however, does not mention where the rca stent was placed, if the turntrac was used as a buddy wire in the pda, or if the rca stent was deployed while the turntrac wire was in the pda.It was reported that no force was used during the wire removal and that the coils of the turntrac wire came off the distal end and were lost in the rca, and no retrieval attempts were made.The condition of the wire within the pda was not reported, so the cause cannot be stated how the coils became separated from the distal portion of the wire.The lost coils did embolize in the distal rca, causing the blood flow to slow, which eventually caused the patient¿s blood pressure to drop.The patient became hemodynamically unstable, cardiopulmonary resuscitation was initiated, and the patient was eventually transferred to another hospital for further care.It was reported that the patient expired 5-6 days post-procedure.The cause of death was unreported.Due to the lack of information provided, it cannot be definitively stated that the turntrac wire was the direct cause of the patient¿s death.Though it is possible that it was an indirect cause of the patient¿s death.¿.

Event Description

Subsequent to the initially filed report, it was reported that the rca and posterior descending arteries (pda) had diffuse disease with 20% calcification, 20% tortuosity.The rca was stented with a xience stent and the turntrac guide wire was used as a second wire.Additionally, the stent was a 3.0x38 mm xience sierra and it was implanted without issue, and there were no adverse patient effects due to the xience sierra stent.No additional information was provided.

• Brand Name: 0.014 HI-TORQUE (HT) TURNTRAC GUIDE WIRE
• 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: 15747814
• MDR Text Key: 303214293
• Report Number: 2024168-2022-11313
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08717648222702
• UDI-Public: 08717648222702
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K173795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 1020013
• Device Catalogue Number: 1020013
• Device Lot Number: 1101961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2021
• 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): Death