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

Catalog Number 1804350-23

Device Problems Material Rupture (1546); Difficult or Delayed Activation (2577); Difficult to Advance (2920)

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

Event Date 02/28/2024

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 heavily calcified left anterior descending artery that is 90% stenosed.Previous stent was noted left main and in stent restenosis (isr) in the target lesion.Atherectomy was performed with a diamondback 360 coronary orbital atherectomy device (oad) in the isr.Pre-dilatation was performed and a 3.5x23mm xience skypoint stent delivery system (sds) was advanced; however, met resistance with anatomy.The stent deployed at 12 atmospheres; however, it was observed that it kept losing pressure.Therefore, once the sds was removed, the stent remained in place but was observed to not be fully expanded.A 1.5x20mm and 2.0x20mm balloons were used to fully expand the stent.Post dilatation was performed with 3.5x12mm balloon.Once the sds was removed from the anatomy it was inflated and a hole was noted on the sds balloon.There was no adverse patient sequela; however, the patient was not discharged untill the following day.No additional information was provided.

Manufacturer Narrative

A visual and functional inspection was performed on the returned device.The reported material rupture was confirmed.The reported difficult to advance and difficult/delayed reaction could not be evaluated as the exact anatomical conditions encountered by the device used during the procedure could not be replicated in the test laboratory.The lot history record (lhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined the reported difficulties and subsequent unexpected medical intervention (additional therapy/non-surgical treatment) appear to be related to the operational context of the procedure, as it is likely that the xience skypoint interacted with heavily calcified, 90% stenosed lesion during advancement, as resistance was noted, causing the reported difficult to advance/position.Further interaction with the challenging anatomy likely contributed to the reported material rupture and observed leak/splash, ultimately causing the reported difficult/delayed activation.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: 18936865
• MDR Text Key: 338068949
• Report Number: 2024168-2024-03514
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233418
• UDI-Public: (01)08717648233418(17)260918(10)3092541
• 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: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1804350-23
• Device Lot Number: 3092541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2023
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 89 KG