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.

• 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
• 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

• Type of Report: Initial,Followup
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 1070275-48
• Device Lot Number: 1111741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2022
• 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 Sex: No Answer Provided
• Patient Weight: KG
• Patient Outcome(s): Required Intervention