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

Catalog Number 1011711-12

Device Problem Off-Label Use (1494)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 06/06/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6- device code 1494 clarifier: indication for use; incorrect anatomy.Attachment: article titled: "stents as bridge to arterial switch operation for d-transposition of great arteries late presenter".

Event Description

This was reported through a research article, identifying the use of xience prime and herculink elite stent.The case study is regarding a 5 month old patient with dextro-transposition of great arteries (d-tga) with intact ventricular septum (ivs) who had low left ventricular mass index, small patent ductus arteriosus (pda) and respiratory failure due to pneumonia.Surgical intervention was considered high risk; therefore, pda stenting was planned.Using a right diagnostic catheter descending aortography revealed a small pda that was pre-dilatated with a 1.5x15mm non-abbott balloon and then stented with a 4.0x12mm xience prime stent.Descending aorta saturation increased from 23 to 80%; however, increasing pulmonary venous flow and stretched patent foramen ovale.A.014 non-abbott guide wire was placed in the upper right pulmonary vein after looped in the left atrium.A 6.0x12mm herculink elite stent was positioned at the interatrial.After stent implantation, descending aorta saturation increased to 91%.When attempting to retrieve the wire under fluoroscopy, it created a false pseudo-dislodgment of the stent.The wire was moved distally across the stent then pulled out again slowly and echocardiography confirmed good stent position.After retrieving the wire, the stent was crumpled to accommodate the anatomy of the patent foramen ovale.The patient had a good recovery and was discharged 1 week later with a planned arterial switch operation (aso).Additional information can be found in the attached article "stents as bridge to arterial switch operation for d-transposition of great arteries late presenter".No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.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.It should be noted that the xience prime everolimus eluting coronary stent system instruction for use states: the xience prime, xience prime sv, and xience prime ll everolimus eluting coronary stent systems are indicated for improving coronary luminal diameter in the following: patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions and for restoring coronary flow in patients experiencing acute myocardial infarction who present within 12 hours of symptom onset.In this case, the instruction for use (ifu) deviation related to incorrect anatomy and indications for use did not cause any device problems.The investigation determined the reported off label use related to incorrect anatomy and indications for use appears to be related to a user error.The reported treatment appears to be related to operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE PRIME 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: 17074354
• MDR Text Key: 316664511
• Report Number: 2024168-2023-05961
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: ID
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 1011711-12
• Device Lot Number: 8102241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• 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): Required Intervention
• Patient Age: 5 MO
• Patient Sex: Male
• Patient Weight: 4 KG