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

Catalog Number 1070300-38

Device Problems Inflation Problem (1310); Component Missing (2306); Device Dislodged or Dislocated (2923)

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

Event Date 09/13/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that before use, when the 3.0x38 mm xience xpedition stent was opened, it was found that the stent was not on the balloon.There was no device use or patient involvement.A new same size xience xpedition stent was used to complete the procedure.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported inflation problem was confirmed.The reported missing component was confirmed as a stent dislodgement.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.The investigation was unable to determine a conclusive cause for the reported inflation problem (pinhole rupture) and component missing (stent).There is no indication of a product quality issue with respect to manufacture, design or labeling.B6 - relevant h6- health effect - impact code 2645 was updated to 2199; medical device problem code 2923 was updated to 2306 and code 1310 was added.

Event Description

It was reported that before use, when the 3.0x38 mm xience xpedition stent was opened, it was found that the stent was not on the balloon.There was no device use or patient involvement.A new same size xience xpedition stent was used to complete the procedure.There was no clinically significant delay in the procedure.Subsequent to the initially filed report, it was reported that the device was advanced in the patient but the stent could not be seen angiographically.The sds attempted to deploy the stent but it did not inflate.The sds was removed from the anatomy.There were no adverse patient effects.No additional information was provided.

• 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: 17882401
• MDR Text Key: 326027531
• Report Number: 2024168-2023-10947
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• 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: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1070300-38
• Device Lot Number: 3050242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2023
• 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