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

Catalog Number UNK XIENCE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Heart Failure/Congestive Heart Failure (4446); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/08/2020

Event Type  Injury  

Manufacturer Narrative

The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat an unspecified lesion.Post stent implantation of a xience stent, worsening heart failure was noted.This was resolved in an unspecified manner.No additional information was provided.

Manufacturer Narrative

This complaint has been captured as a non-complaint product experience as there was no device malfunction or patient effect associated with the device; thus, investigation is not required.D6a: implant date.H6: health effect - clinical code 4446 - removed.H6: health effect - impact code 4614 - removed.H6: medical device problem code 2993 - removed.

Event Description

Subsequent to the initial medwatch report, the following information was received: it was reported that on 06/23/2020, the patient was hospitalized for obstructive pyelonephritis.On (b)(6) 2020, the patient experienced heart failure from acute coronary syndrome and unstable angina.90% stenosis was noted in the left anterior descending (lad) coronary artery and a xience stent was successfully implanted, resolving the event.The patient experienced a full recovery at that time.

• Brand Name: XIENCE 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: 14838098
• MDR Text Key: 295047989
• Report Number: 2024168-2022-06941
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK XIENCE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 71 KG