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

Model Number 1804250-18

Device Problems Material Rupture (1546); Difficult or Delayed Activation (2577); Patient-Device Incompatibility (2682)

Patient Problems Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914)

Event Date 09/08/2022

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a mid circumflex artery that was 90% stenosed.The lesion was pre-dilated with a 2.5x15mm nc trek at 2 inflations without issue.Then a 2.5x18mm xience skypoint stent was advanced to the lesion without issue.Deployment was initiated and the stent partially deployed, when it was noted that the stent-balloon could not be pressurized past 2 atmospheres and leakage was noted coming from a pinhole on the balloon.The stent implant had partially deployed at the lesion (not well apposed to the vessel wall), so it was decided to remove the delivery system.The patients pressure immediately dropped and ekg changes were noted.The patient became unresponsive for 30 seconds.Medication was administered and the patients vitals stabilized and returned to normal.Then a 1.5x8mm and a 2.5mm balloons were used to fully implant the xience implant successfully.The patient is fine.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported material rupture was confirmed.The reported wall apposition could not be replicated in a testing environment as they are related to operational context of the procedure.The reported delayed/difficult activation could not be confirmed as the stent was not returned.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 hypotension 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 material rupture; however, factors that may contribute to material ruptures include, but are not limited to, material damage, interactions with other devices or interaction with lesion calcification and tortuosity.The reported difficult activation of the stent, wall apposition and subsequent treatment appear to be related to operational context as it is likely the ruptured balloon and was unable to fully expand the stent to the vessel wall.The reported patient effects are known inherent risks of the procedure.Additionally, there was no damage or leak noted to the stent delivery system (sds) during the inspection prior to use or during preparation of the device, which suggests a product quality issue did not contribute to the reported difficulties.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: 15499328
• MDR Text Key: 300725775
• Report Number: 2024168-2022-10076
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233081
• UDI-Public: 08717648233081
• 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: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1804250-18
• Device Catalogue Number: 1804250-18
• Device Lot Number: 2051341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2022
• 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; Life Threatening
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 81 KG