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

Catalog Number 1800400-18

Device Problems Material Deformation (2976); Packaging Problem (3007)

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

Event Date 07/25/2022

Event Type  malfunction  

Manufacturer Narrative

A visual inspection was performed on the returned device.The reported packaging problem was confirmed.The reported material deformation was not confirmed.It was observed that the hypotube was separated.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 other incidents.A conclusive cause for the reported difficulties could not be determined.Factors that could contribute to material deformation prior to use include, but are not limited to, damage during manufacturing, inadvertent mishandling during unpackaging, sheath/stylet removal or during preparation of the device.Potential factors that may contribute to a packaging problem include, but are not limited to, mishandling during manufacturing/shipping, during receiving/storage at the account, and/or handling during removal from packaging.In this case, it is possible that inadvertent mishandling during unpackaging of the device contributed to the reported packaging problem (kinked coil), causing a kink in the shaft which contributed to the observed material separation (hypotube); however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that during preparation of the 4.00x18mm xience skypoint stent delivery system (sds) a kink was noted in the hoop dispenser packaging and stent due to the damage.There were no other device issues as shaft separation and stent dislodgement.There was no device use or patient involvement, and there was no clinically significant delay in the procedure.An unspecified stent was used to complete the procedure.Returned device analysis identified a separation at the same location of the kink; however, the account stated that they were not aware of the separation.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: 16566648
• MDR Text Key: 311516472
• Report Number: 2024168-2023-02797
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1800400-18
• Device Lot Number: 2042542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2022
• 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