MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE PRO 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1017300-48

Device Problem Difficult to Remove (1528)

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

Event Date 02/05/2024

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 pro 48 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 during preparation of the 3.0x48mm xience pro stent delivery system (sds), the stent was sticking onto the protective sheath and was noted to be faulty.There was no device use or patient involvement.There was no reported clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE PRO 48 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: 18789907
• MDR Text Key: 336438263
• Report Number: 2024168-2024-02421
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: UK
• 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: Other
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1017300-48
• Device Lot Number: 3100441
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2023
• 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
• Treatment: PROTECTIVE SHEATH OF XIENCE PRO