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

Catalog Number 1508350-28

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

Patient Problem Hypoxia (1918)

Event Date 05/24/2022

Event Type  Injury  

Manufacturer Narrative

The device has returned for investigation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The xience pros device is currently not commercially available in the us; however, it is similar to a device sold in the us.

Event Description

It was reported the procedure was to treat a left anterior descending artery.The 3.5x28mm xience pros stent delivery system (sds) was deployed successfully; however, during removal resistance was noted and the sds shaft separated.The separated portion could not be retrieved when attempting to remove the device, therefore, the patient had to be transferred to the heart surgery department where the separated portion was recovered via open surgery.After surgery the patient had to be connected to the heart-lung machine [ventilator] which is still ongoing.There was no clinically significant delay reported.No additional information was provided.

Manufacturer Narrative

A visual inspection was 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 revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents 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.Additionally, the reported removal of foreign body and surgical intervention were due to a material separation within the anatomy.Factors that may contribute to a material separation (shaft) post deployment include, but are not limited to, interaction with accessory devices, withdrawal technique, and/or anatomical characteristics.Factors that may contribute to a difficult to remove post deployment include, but are not limited to, damage to the device, interaction with challenging anatomy, interaction with accessory devices, and/or insufficient support.In this case, it is possible that the stent delivery system (sds) interacted with challenging anatomy and/or an accessory device during withdrawal, as resistance was noted, contributed to the reported difficult to remove, noted stretched inner/outer member, and subsequent material separation (shaft); however, this cannot be confirmed.Additionally, it was noted that the patient had to be transferred to the heart surgery department where the separated portion of the sds was recovered via open surgery.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: XIENCE PROS 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: 14697045
• MDR Text Key: 294037398
• Report Number: 2024168-2022-06411
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1508350-28
• Device Lot Number: 1042041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2021
• 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): Disability; Hospitalization; Required Intervention