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

Catalog Number 1800225-18

Device Problems Leak/Splash (1354); Activation Failure (3270)

Patient Problem Air Embolism (1697)

Event Date 03/23/2022

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.Na.

Event Description

It was reported that the procedure was to treat a highly calcified circumflex marginal artery.When attempting to inflate at first inflation and deploy a 2.25x18mm xience skypoint, the stent-balloon did not inflate and contrast media was noted leaking causing an air bubble that blocked the artery.Clinically significant delay was reported to remove the air bubble as mechanical thrombectomy (aspiration) was performed.The device was removed and troubleshooted outside of the patient when the leak was confirmed between the sheath and the hypotube.Prolonged hospitalization was reported, but the patient is currently fine.Another stent was used to treat the original target lesion.No additional information was provided.

Manufacturer Narrative

A visual and functional inspection were performed on the returned device.The reported activation failure including expansion failures and leak were confirmed.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.The reported patient effect of an air embolism is listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported difficulties.Additionally, a conclusive cause for the reported patient effect, and its relationship to the product, if any, cannot be determined; however, the subsequent treatments and delay to treatment/ therapy appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling of the device.

• 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: 14136576
• MDR Text Key: 289449670
• Report Number: 2024168-2022-04118
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: FR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1800225-18
• Device Lot Number: 1091542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2021
• 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; Hospitalization