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

Catalog Number 1125350-08

Device Problems Difficult To Position (1467); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2018

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.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a stenosed lesion in the mid and proximal right coronary artery (rca).Pre-dilatation was performed with multiple unknown non-compliant balloon catheters.A 3.5x8mm xience alpine stent delivery system (sds) was advanced into the mid rca; however, the sds would not cross the proximal rca due to the anatomy.The sds was removed and additional pre-dilatation was performed.The same sds was re-advanced; however, resistance advancing it through the guide catheter was felt.The second interventional guide wire was removed and the sds was re-inserted again but still felt different and would not cross the proximal lesion in the rca.The sds was removed and after removal, it was noticed that the stent had dislodged off the balloon.All devices were removed from the patient anatomy and it was confirmed that the stent dislodged inside the guide catheter.The procedure was successfully completed with balloon angioplasty with a non-abbott balloon dilatation catheter.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Evaluation summary: a visual and dimensional inspection was performed on the returned device.The reported stent dislodgement was confirmed.The reported failure to advance and device operates differently could not be tested as it was based on operational circumstances.The reported difficult to position could not be tested due to the condition of the returned device.It was reported that the xience alpine was reinserted following additional pre-dilatation.The xience alpine everolimus eluting coronary stent system instructions for use (ifu) 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 when retracting the undeployed stent back into the guiding catheter.It is unknown if the ifu deviation contributed to the reported event.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 difficulties appear to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: XIENCE ALPINE 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: 7582508
• MDR Text Key: 110921153
• Report Number: 2024168-2018-04308
• 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,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2021
• Device Catalogue Number: 1125350-08
• Device Lot Number: 7121361
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/04/2018
• Date Manufacturer Received: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER: GUIDELINER
• Patient Age: 57 YR
• Patient Weight: 113