MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE PRIME BTK EVEROLIMUS ELUTING PERIPHERAL STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1012650-38

Device Problems Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/18/2021

Event Type  Injury  

Manufacturer Narrative

The device was received. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the 4. 0x38mm xience prime btk stent delivery system (sds) was attempted to advance over the. 014 unspecified guide wire; however, resistance was felt with the guide wire. When attempting to pull back the sds, the shaft separated, which remained on the guide wire. It was noted resistance was also felt during removal with the guide wire. Additionally, the stent dislodged and migrated into the profunda femoral artery. The separated shaft portion was retrieved on the guide wire and the stent was left free floating. Patient is in good conditional and a follow up will be performed. There was no clinically significant delay in the procedure. No additional information was provided.

• Brand Name: XIENCE PRIME BTK EVEROLIMUS ELUTING PERIPHERAL 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: 12787179
• MDR Text Key: 280584375
• Report Number: 2024168-2021-10197
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: FR
• 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

• Type of Report: Initial,Followup
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/19/2022
• Device Catalogue Number: 1012650-38
• Device Lot Number: 0051342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/10/2021 Patient Sequence Number: 1