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

Catalog Number 1070300-15

Device Problem Material Separation (1562)

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

Event Date 11/14/2023

Event Type  malfunction  

Event Description

It was reported that upon unpackaging of the 3x15mm xience xpedition stent delivery system (sds), the shaft was noted to be broken [separated].The sds was not used in the procedure.There was not patient involvement and no clinically significant delay reported in the procedure.Another stent was used to complete 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.

Event Description

Subsequent to the initial report, return device analysis found the stent delivery system (sds) was returned with blood in the balloon folds, in the guide wire lumen.There was contrast on the device.The procedure was to treat an 80% stenosed lesion in the left anterior descending (lad) artery.No additional information was provided.

Manufacturer Narrative

A visual inspection was performed on the returned device.The reported material separation was confirmed.A review of the production records was performed and revealed no related complaint assessment or manufacturing nonconformities.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation was unable to determine a conclusive cause for the reported material separation.It was reported that the stent delivery system¿s shaft separated during removal from the dispenser.Factors that may contribute to a shaft separation during unpackaging include, but are not limited to, damage incurred during manufacturing, damage incurred during shipment, or inadvertent mishandling during unpacking or preparation.In this case, analysis of the returned device noted the fracture face of the separation to be oval.This type of damage is consistent with force applied at a kink or bend.It is possible that inadvertent mishandling during unpackaging contributed to the reported shaft separation and the noted inner/outer member damage.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: patient code 2645 was removed and the patient code 2199 was added.

• Brand Name: XIENCE XPEDITION 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: 18983294
• MDR Text Key: 338669468
• Report Number: 2024168-2024-03703
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648157882
• UDI-Public: (01)08717648157882(17)250711(10)2070542
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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: 05/14/2024

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: 1070300-15
• Device Lot Number: 2070542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2022
• 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