MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1500300-23

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that during preparation of a 3.0 x 23mm xience sierra stent delivery system (sds), the protective sheath was difficult to remove from the sds.Force was applied, and then the protective sheath was finally removed.It was noted that the stent and protective sheath became wrinkled.An attempt was made to advance the sds with an unspecified guide wire outside the patient's body, but the sds could not could not be positioned with the guide wire.The sds was not used in the patient and the procedure was successfully completed with a 3.0 x 23 mm xience sierra sds.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

A visual and dimensional inspection was performed on the returned device.The reported twisted/bent material was confirmed.The reported stent damage could not be confirmed during return analysis testing.The reported difficult to remove could not be tested as the protective sheath was not returned.The reported difficult to advance could not be tested due to the condition of the returned device.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 did not indicate a lot specific quality issue.The investigation determined the reported difficult to remove, difficult to advance and twisted/bent material appear to be related to circumstances of the procedure, as it is likely that inadvertent mishandling during protective sheath/stylet removal, as resistance was noted, contributed to the reported difficult to remove the protective sheath, bent/twisted material and noted inner/outer member stretching.Further manipulation of the device in an attempt to load the stent delivery system (sds)over the guide wire likely contributed to the noted bunched inner member, stretched guide wire exit notch and inner member break, ultimately causing the reported difficulty to advance.The investigation was unable to determine a conclusive cause for the reported stent damage as it could not be confirmed during return analysis testing; however, factors that could contribute to material deformation include, but are not limited to, damage during manufacturing, inadvertent mishandling during sheath/stylet removal, preparation, during use of the device, interaction with accessory devices, patient anatomical morphology or patient disease state.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.H6: device code 2017 was removed.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10497303
• MDR Text Key: 207041179
• Report Number: 2024168-2020-07420
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2022
• Device Catalogue Number: 1500300-23
• Device Lot Number: 9120341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1