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

Catalog Number 1070275-48

Device Problems Material Separation (1562); Activation Failure (3270)

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

Event Date 05/23/2022

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat the right coronary artery (rca).A first stent was successfully deployed, however, while the 2.75x48mm xience xpedition stent delivery system (sds) had no resistance during advancement the physician could not release the stent and it only partially deployed.Upon removal, the sds was observed to have separated.There was no resistance during removal.A catheter was advanced and managed to retrieve the other parts of the sds.There were no pieces of the device left in the anatomy.Another xience xpedition stent was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned 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/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.Factors that may contribute to a stent expansion failure include, but are not limited to, contrast-saline concentration, damage to the inflation lumen, damage to the balloon, patient¿s anatomical condition, loose connection with the indeflator, and/or inflation technique.Factors that may contribute to a material separation (stent) include, but are not limited to, tensile strength, corrosion, excessive force applied to device, interaction with accessory devices, and/or interaction with challenging anatomy.In this case, there was no damage or anomalies noted to the stent delivery system (sds) during the inspection prior to use or during preparation for use which suggests a product quality issue did not contribute to the reported difficulties.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported difficulties.Additionally, the separated portion of the stent delivery system was retrieved from the anatomy via a catheter.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D9/h3 - device available for eval updated from 'yes' to 'no'.

• 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: 14672334
• MDR Text Key: 294860420
• Report Number: 2024168-2022-06295
• 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: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1070275-48
• Device Lot Number: 1111741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/12/2022
• Supplement Dates Manufacturer Received: 11/10/2022
• Supplement Dates FDA Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2021
• 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 Outcome(s): Required Intervention