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

Catalog Number UNK XIENCE SKYPOINT

Device Problems Deflation Problem (1149); Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017)

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

Event Date 10/18/2022

Event Type  Injury  

Event Description

It was reported that the procedure was to treat the right coronary artery (rca) with moderate tortuosity and mild calcification.The xience skypoint stent was implanted; however, after deployment the balloon of the delivery system would only partially deflate.There was resistance during removal and a non-abbott guide catheter extension was advanced to push the partially deflated balloon inside so it could be removed from the anatomy.The balloon was removed partially deflated.The contrast mix was 90% saline and 10% contrast and the device was not prepped (air aspiration) outside the anatomy prior to use.There were no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

The udi # is unknown due to the part/lot number was not provided.(b)(4).Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.A review of the electronic lot history record (elhr), corrective action tracking system for the web (catsweb) database review and similar incident query for this product was not performed because the part/lot numbers were not reported.It was reported that the contrast mixture used during the procedure was 90% saline and 10% contrast.It should be noted that the xience skypoint instructions for use (ifu) states: use contrast diluted 1:1 with heparinized normal saline.In this case, it is possible that the ifu deviation contributed to the reported deflation problem.Additionally it was reported that the device was not prepared outside the anatomy.It should be noted that the ifu states: prepare an inflation device / syringe with diluted contrast medium.Attach an inflation device / syringe to the stopcock; attach it to the inflation port.With the tip down, orient the delivery system vertically.Open the stopcock to delivery system; pull negative for 30 seconds; release to neutral for contrast fill.Close the stopcock to the delivery system; purge the inflation device / syringe of all air.It is unknown if the ifu deviation(s) directly caused or contributed to the reported event.The investigation was unable to determine a conclusive cause for the reported deflation problem; however, the reported difficult to remove and subsequent treatment appears to be related to the operational context of the procedure.Factors that may contribute to a deflation problem include, but are not limited to, contrast mixture, procedural contaminants in the inflation lumen, damage to the inflation lumen, deflation technique, and/or loose connection with the indeflator.In this case, it is possible that the contrast mixture of 90% saline and 10% contrast used during the procedure may have contributed to the reported deflation problem; however, this cannot be confirmed.Additionally, it is likely that the balloons inability to fully deflate contributed to the reported difficulty removing [entrapment] the balloon from the anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.

• Brand Name: XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY 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: 15780697
• MDR Text Key: 303552464
• Report Number: 2024168-2022-11496
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK XIENCE SKYPOINT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 11/11/2022
• 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): Required Intervention