MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1500200-38

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2022

Event Type  malfunction  

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.The rca was stented with a 3.0x38 mm xience sierra and the turntrac guide wire was used as a second wire.The xience sierra stent was implanted without issue, and there were no adverse patient effects due to the xience sierra stent.No additional information was provided.

Manufacturer Narrative

The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional 014 ht turntrac device referenced is filed under separate medwatch report number.

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.

Manufacturer Narrative

The device was not returned for analysis.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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty to remove (guidewire); however, factors that may contribute to difficulty removing the guide wire 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.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; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16009311
• MDR Text Key: 306886415
• Report Number: 2024168-2022-12832
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: HK
• PMA/PMN Number: P110019
• 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
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2023
• Device Catalogue Number: 1500200-38
• Device Lot Number: 0120341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2020
• 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
• Treatment: TURNTRAC GUIDE WIRE