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

Model Number 1804350-15

Device Problem Material Rupture (1546)

Patient Problems Air Embolism (1697); Ischemia (1942)

Event Date 01/08/2022

Event Type  Injury  

Manufacturer Narrative

The stent remains in patient.The device will not be returned for evaluation.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 a left anterior descending (lad) artery that is 90% stenosed.After pre-dilatation was performed with an unspecified balloon dilatation catheter the 3.5x15mm xience skypoint stent delivery system (sds) was delivered and was inflated to 12 atmospheres; however, the balloon ruptured.Contrast medium flowed to the distal lad and air leaked at the same time causing a slow-flow.Nitroglycerin was administered and the blood flow stabilized.The stent was expanded properly with the kissing balloon technique to fully appose the stent into the vessel wall.There was no clinically significant delay reported.The physician¿s opinion was that this was a xience skypoint related interaction since there was no calcification in the lesion and there was no problem with the pre-dilatation.Prior to use, the catheter was soaked in saline.The device was prepped (air aspiration) outside the anatomy.No resistance was met when the protective sheath was removed.No resistance was met during advancement or removal.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 other incidents from this lot.The reported patient effects of ischemia and embolism (air) are listed in the xience skypoint everolimus eluting coronary stent systems instructions for use (iuf) as known patient effects of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported material rupture.The patient effects and treatment appear 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 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: 13416256
• MDR Text Key: 284825296
• Report Number: 2024168-2022-01067
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233395
• UDI-Public: 08717648233395
• Combination Product (y/n): Y
• Reporter Country Code: JA
• 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: 03/01/2022

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 Expiration Date: 08/27/2024
• Device Model Number: 1804350-15
• Device Catalogue Number: 1804350-15
• Device Lot Number: 108234A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 02/01/2022
• Supplement Dates Manufacturer Received: 02/09/2022
• Supplement Dates FDA Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2021
• 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