MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1550225-18

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Angina (1710); Non specific EKG/ECG Changes (1817)

Event Date 02/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide catheter: guideliner; stent: 3.0x38mm xience sierra.(b)(4).The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the patient presented with myocardial infarction and the procedure was performed to treat tortuous lesion in the diagonal coronary artery.The left anterior descending (lad) coronary artery had been previously stented with a 3.0x38mm xience sierra stent without issue.A 2.25x18mm xience sierra stent delivery system (sds) was advanced to treat the diagonal branch but could not cross, as the stent got caught on the tortuous bend and struts of the previously implanted stent.The sds was subsequently removed, and a non-abbott sds was then advanced to treat the diagonal coronary artery; however, the sds also could not cross and was subsequently removed.An unspecified non-compliant balloon catheter was then used to pre-dilate to create more room.The same xience sierra was then re-advanced in the patient anatomy with a non-abbott guide catheter but still could not cross, and the sds was then removed from the patient without resistance; however, the stent had dislodged.It was thought that the stent had been successfully retrieved from the patient anatomy in the guide catheter; therefore, the procedure concluded without any additional treatment.Two hours post-procedure, the patient experienced st elevation and chest pain.It was then noted under angiography that the stent had remained in the vessel.An unspecified balloon was used to crush the stent to the lad vessel wall.There was no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).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 should be noted that the xience sierra, everolimus eluting coronary stent system, instructions for use (ifu) states: an unexpanded stent may be retracted into the guiding catheter one time only.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 determined the reported difficulties and subsequent treatment appear to be related to the operational context of the procedure.The reported patient effect of angina is listed in the xience sierra ifu as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect(s) and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8388473
• MDR Text Key: 137789842
• Report Number: 2024168-2019-01654
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2021
• Device Catalogue Number: 1550225-18
• Device Lot Number: 807044A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 117