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

Catalog Number 1070250-48

Device Problems Material Separation (1562); Deformation Due to Compressive Stress (2889)

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

Event Date 11/27/2023

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat the anterior diagonal coronary artery with heavy calcification, heavy tortuosity and 95% stenosis.During advancement of the 2.5x48 mm xience xpedition stent delivery system (sds) through the lesion, there was a separation of the proximal shaft near the hub.A photo provided shows a kinked proximal shaft.The separated portion was simply withdrawn.There was no resistance during advancement or removal.A non-abbott device was used to complete the procedure.There were no adverse patient effects and there was a delay in the procedure; however there was no injury to the patient.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

A visual inspection was performed on the returned device.The reported material separation and deformation due to compressive stress were confirmed.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.A conclusive cause for the reported difficulties could not be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: XIENCE XPEDITION 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: 18314725
• MDR Text Key: 330428992
• Report Number: 2024168-2023-13886
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CO
• 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: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1070250-48
• Device Lot Number: 3050941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2023
• 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
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 47 KG