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

Catalog Number 1011709-38

Device Problems Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)

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

Event Date 04/12/2023

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a lesion in the anterior tibial artery.A 3.0x38mm xience prime drug eluting stent (des) was advancing on an unspecified.014 guide wire (gw) when the des became stuck with the guide wire outside of the anatomy and could not be advanced into the sheath.The des could not be removed from the guide wire as the two devices were stuck together, so the surgeon cut and removed the guide wire and exchanged it with a new one.When the surgeon cut the guide wire, the shaft of the des separated.A new 3.0x38mm xience prime des and guide wire were used to successfully complete the procedure.There were no reported adverse patient effects and no clinically significant delays in the procedure.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Manufacturer Narrative

The device was returned for analysis.The reported material separation was confirmed.The reported difficulty to advance and difficulty to remove could not be confirmed due to the condition the device was received 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 difficulties; however, factors that may contribute to the difficult advancing and removing the stent delivery system (sds) from the guide wire causing resistance between the devices may include, but are not limited to, manufacturing damage, device placement technique, buildup of procedural contaminants in the guide wire lumen, inner diameter of guide wire lumen, condition of the guide wire, or damage to the distal shaft of the catheter.Additionally, factors that may contribute to a material separation (shaft) include, but are not limited to, excessive force applied to device during use, interaction with accessory devices, and/or interaction with the patient¿s anatomy.It should be noted the account indicated the guidewire was cut to remove the system at which time any damage to the stent delivery system would have occurred.It is unclear if the separation occurred when the guidewire was cut or if it separated due to case circumstances, the account was not able to be more specific when additional information was requested.Based on the information provided it is unknown what may have caused the reported material separation (shaft).Based on the information provided and without the return of the complete delivery system a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE PRIME LL 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: 17309307
• MDR Text Key: 318985009
• Report Number: 2024168-2023-07424
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: AS
• 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: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1011709-38
• Device Lot Number: 2040641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2022
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 38 KG