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

Catalog Number 1500400-38

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

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 the procedure was to treat st elevation mi (st-segment elevation myocardial infarction) due to a blocked, mildly calcified, tortuous right coronary artery (rca).During advancement of the 4x38mm xience sierra drug eluting stent system (des), resistance was noted through the guide catheter so a guideliner was inserted, but the device became stuck in the guideliner.Both the stent system and guideliner were removed as a single unit.There was no adverse patient effect or a clinically significant delay in the procedure.A non-abbott stent was implanted to successfully complete the procedure.No additional information was provided.

Manufacturer Narrative

H6: device code 2017 - reinsertion.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.It was reported that the xience sierra was advanced, but met resistance with the guide catheter and was removed, then the same device was reinserted.It should be noted that the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use (eifu) states: an unexpanded stent may be retracted into the guiding catheter one time only.An unexpanded stent should not be reintroduced into the artery once it has been pulled back into the guiding catheter.Subsequent movement in and out through the distal end of the guiding catheter should not be performed, as the stent may be damaged or dislodge during retraction back into the guiding catheter.It is unknown if the ifu deviation directly caused or contributed to the reported event.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.D10, h3: device not available for evaluation.

Manufacturer Narrative

Visual, functional, and dimensional inspection was performed on the returned device.The reported difficult to advance/position and difficult to remove was not confirmed.The returned sds was advanced through and removed from a proxy 6f guiding catheter with no resistance noted.D9, h3: device was available for evaluation h6: type of investigation code 4114 - removed.H6: investigation conclusions code 4315 - 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: 10525141
• MDR Text Key: 207037489
• Report Number: 2024168-2020-07619
• 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,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2022
• Device Catalogue Number: 1500400-38
• Device Lot Number: 9080241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Date Manufacturer Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6FRENCH AL1 GUIDE CATHETER