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

Catalog Number 1804250-15

Device Problems Unintended System Motion (1430); Material Rupture (1546)

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

Event Date 08/20/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat a 99% stenosed de novo lesion in the proximal left anterior descending (plad).Pre-dilatation was performed.The 2.5x15mm xience skypoint stent delivery system (sds) was prepped (air aspiration) outside the anatomy prior to use.The sds was advanced to the target lesion; however, the balloon ruptured during the first inflation at 3 or 4 atmospheres.The stent was noted as not sufficiently deployed due to the balloon rupture.Therefore, the sds was removed and a non-abbott balloon was used to fully deploy the xience skypoint stent.During deployment the stent became displaced about 2mm from the intended implant position; however, the stent was implanted in the target lesion.There was no adverse patient sequela and no clinically significant delay in procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported material rupture was confirmed.The reported unintended system motion could not be replicated in a testing environment as it was related to operational context of the procedure.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 material rupture; however, factors that may contribute to material ruptures include, but are not limited to, material damage, materials, inflation technique, interactions with other devices, lesion calcification and tortuosity or insufficient preparation prior to use.The product risk assessment identifies this as a foreseeable event; as such, design and manufacturing controls and mitigations have been established for potential causes.There was no damage noted to the sds during the inspection prior to use or during preparation for use which suggests a product quality issue did not contribute to the reported difficulties.In this case, it is possible the device became damaged due to interaction with accessory devices and/or the 99% stenosed lesion during the procedure, thus causing the reported material rupture (balloon pinhole); however, this cannot be confirmed.The reported unintended system motion and treatment appears to be related to operational context of the procedure as it is likely the balloon catheter used for post-dilation interacted with the deployed stent causing the reported unintended system motion.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: 17740769
• MDR Text Key: 323331623
• Report Number: 2024168-2023-10022
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233074
• UDI-Public: 08717648233074
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1804250-15
• Device Lot Number: 3010241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2022
• 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