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

Catalog Number 1017300-48

Device Problems Material Separation (1562); Device Dislodged or Dislocated (2923); Activation Failure (3270)

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

Event Date 12/09/2021

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat the popliteal trunk with occlusion. A non-abbott guide wire was placed and then the 3. 0x48 mm xience pro stent delivery system (sds) was advanced into the passage of the occlusion. The sds could not be inflated and the proximal shaft separated. The separated portion of the shaft was simply withdrawn. Then stent dislodged but was removed with the guiding catheter. A new, same size xience stent was used to complete the procedure. There were no adverse patient effects and there was no reported clinically significant delay in the procedure. No additional information was provided.

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.

• Brand Name: XIENCE PRO 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: 13087990
• Report Number: 2024168-2021-12167
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 1017300-48
• Device Lot Number: 1012041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sex: No Answer Provided
• Patient Weight: KG