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

Catalog Number 1550350-18

Device Problems Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the 3.5x18 mm xience sierra stent delivery system (sds) was prepped normally and was advanced to the lesion without issue.It was noted that the stent was unable to be seen on angio.The balloon was inflated anyway and the stent still could not be seen.The sds was removed and it was noted that the stent was located on the stylet on the table and had not entered the patient.Another, same size xience sierra stent was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number (b)(4).Evaluation summary: a visual and dimensional inspection was performed on the returned device.The reported dislodgement was confirmed during visual inspection.It should be noted that the xience sierra everolimus eluting coronary stent system instruction for use (ifu), the following is stated: prior to using the xience sierra 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.In this case, the ifu deviation did not contribute to the reported stent dislodgement.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.The investigation determined the reported dislodgement appears to be related to operational context as it is likely that inadvertent mishandling during protective sheath removal resulted in the reported stent dislodgment.There is no indication of a product quality issue with respect to design, manufacture or labeling.

• 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: 8642557
• MDR Text Key: 146227722
• Report Number: 2024168-2019-04118
• 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: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2019
• Device Catalogue Number: 1550350-18
• Device Lot Number: 8102241
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/14/2019
• Date Manufacturer Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR