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

Catalog Number 1804300-08

Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)

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

Event Date 08/15/2023

Event Type  Injury  

Event Description

It was reported that the procedure was performed to treat a lesion in the circumflex coronary artery with no calcification and no tortuosity.The 3.0x08 xience skypoint stent delivery system (sds) was advanced to the lesion and then prepped.Inflation was attempted.The balloon was able to get to 16 atmospheres after one inflation; however, the device was not holding pressure and a rupture was noted.The stent was 90% deployed.A non-compliant (nc) balloon was used for post-dilatation to complete deployment of the stent.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: device code 2017 clarifier: incorrect prep.

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.The investigation was unable to determine a conclusive cause for the reported difficulties.The reported treatment appears to be related to operational context of the procedure.It was reported xience skypoint stent delivery system (sds) was advanced to the lesion and then prepped, and then inflation was attempted.It should be noted that the xience skypoint everolimus eluting coronary stent system instruction for use states: while introducing the delivery system into the vessel, do not induce negative pressure on the delivery system.This may cause dislodgement of the stent from the balloon.In this case, it does not appear the instruction for use (ifu) deviation related to incorrect stent preparation contributed to the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that the procedure was performed to treat a lesion in the circumflex coronary artery with no calcification and no tortuosity.The 3.0x08 xience skypoint stent delivery system (sds) was advanced to the lesion and then prepped, and then inflation was attempted.The balloon was able to get to 16 atmospheres after one inflation; however, the device was not holding pressure and a rupture was noted.The stent was 90% deployed.A non-compliant (nc) balloon was used for post-dilatation to complete deployment of the stent.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.

• 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: 17671692
• MDR Text Key: 322523835
• Report Number: 2024168-2023-09575
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233210
• UDI-Public: 08717648233210
• 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,Followup
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1804300-08
• Device Lot Number: 3041341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2023
• 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
• Treatment: NON-COMPLIANT (NC) BALLOON
• Patient Outcome(s): Required Intervention