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

Catalog Number 1508225-12

Device Problems Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Material Deformation (2976)

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

Event Date 02/23/2024

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.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 that the procedure to treat a lesion in an unspecified artery.The 2.25x12mm xience pros stent delivery system (sds) was attempted to be used in the procedure; however, the sds met with resistance upon entering the guide catheter.Therefore, the sds was removed and the stent was noted to be no longer positioned correctly on the delivery system and had become deformed.Another xience pros stent was used to complete the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported material deformation was confirmed.The reported stent dislodgement was not confirmed.The reported difficulty to advance could not be replicated in a testing environment as it was related to operational context of the procedure.Lot history record (lhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the guide catheter during advancement causing the reported difficulty to advance and subsequent material deformation.The reported stent dislodgement could not be confirmed during return analysis of the device; however, it is possible that the material deformation (lifted, bent, stretched, overlapping struts) was identified as a dislodgement by the account.There is no indication of a product quality issue with respect to manufacture, design or labeling.The xience pros device is currently not commercially available in the us; however, it is similar to a device sold in the us.

• 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: 18889969
• MDR Text Key: 337510629
• Report Number: 2024168-2024-03230
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648295126
• UDI-Public: (01)08717648295126(17)260903(10)3090741
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1508225-12
• Device Lot Number: 3090741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 04/16/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2023
• 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