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

Model Number 1804300-23

Device Problems Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577); Contamination /Decontamination Problem (2895)

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

Event Date 09/21/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The stent is implanted; however, the pouch and the foreign material will return.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 mildly calcified, mildly tortuous de novo proximal left anterior descending artery that is 99% stenosed.Upon removing the 3.0x23mm xience skypoint stent delivery system from the pouch it was noted fibers were inside the sterilized pouch and not on the stent or dispenser coil.Pre-dilatation of the lesion was performed with non-abbott balloons and the 3.0x23mm xience skypoint was implanted.Post-dilatation was performed with a non-abbott balloon at the proximal end of the stent to complete the procedure without issues.There were no adverse patient effects and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

A visual inspection and chem analysis were performed on the returned packaging.The reported contamination/decontamination problem was confirmed.The reported difficult/delayed activation could not be tested as it was based on operational circumstances.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.It was reported that there was red fibrous contamination observed inside the tyvek pouch during unpackaging of the xience skypoint; however, the device was still used inside the anatomy.It should be noted that the xience skypoint, everolimus eluting coronary stent system (eecss), electronic instructions for use (ifu) states: carefully inspect the sterile package before opening and check for damage to the sterile barrier.Do not use if the integrity of the sterile package has been compromised.Prior to using the xience skypoint stent system, carefully remove the system from the package and inspect for bends, kinks, and other damage.Verify that the stent does not extend beyond the radiopaque balloon markers.Do not use if any defects are noted.Do not manipulate, touch, or handle the stent, which may cause coating damage, contamination, or stent dislodgement from the delivery balloon.It is unknown if the ifu deviation contributed to the reported event.In addition, a chem analysis was performed on the returned fibrous material reportedly observed inside the tyvek pouch.It is possible the confirmed smock fiber (polypropylene) found inside the tyvek pouch may have occurred while removing the device from the packaging prior to use causing the reported contamination / decontamination problem; however, a definitive cause for the reported difficulties cannot be determined.The investigation was unable to determine a conclusive cause for the reported difficulties; however, the subsequent treatment appears to be related to circumstances of the procedure.Difficulty deploying the stent (difficult or delayed activation) may be attributed to several factors including, but are not limited to, stent placement, patient anatomical morphology (calcification, tortuosity), inflation technique during use of the product or undersizing of the vessel.Factors that may contribute to a contamination / decontamination problem include, but are not limited to, manufacturing, during shipment, storage or unpackaging of the device.In this case, it is possible the stent interacted with the mildly calcified, mildly tortuous, 99% stenosed lesion during deployment, as the proximal portion was not fully apposed to the vessel wall, causing the reported difficult or delayed activation.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 to treat a mildly calcified, mildly tortuous de novo proximal left anterior descending artery that is 99% stenosed.Upon removing the 3.0x23mm xience skypoint stent delivery system from the pouch it was noted fibers were inside the sterilized pouch and not on the stent or dispenser coil.Pre-dilatation of the lesion was performed with non-abbott balloons and the 3.0x23mm xience skypoint was implanted.Post-dilatation was performed with a non-abbott balloon at the proximal end of the stent to complete the procedure without issues.There were no adverse patient effects and no clinically significant delay.Subsequent to the initial being filed it was confirmed the proximal portion was not fully apposed to the vessel wall; therefore, post-dilatation was performed.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: 12635869
• MDR Text Key: 276589727
• Report Number: 2024168-2021-09238
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233258
• UDI-Public: 08717648233258
• 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: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2023
• Device Model Number: 1804300-23
• Device Catalogue Number: 1804300-23
• Device Lot Number: 0102141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2020
• 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