MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1070250-48

Device Problems Deflation Problem (1149); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2019

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 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 procedure was to treat a moderately tortuous and heavily calcified proximal right coronary artery that was 80% stenosed.Pre-dilatation was performed and a 2.5 x 48 mm xience xpedition stent was advanced and initially met resistance with the anatomy.The stent was deployed once at 14 atmospheres; however, it was initially difficult to deflate the stent delivery balloon.The balloon was then ultimately deflated completely.The device was not prepped outside the anatomy prior to use.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Event Description

Subsequent to the initial report, additional information was received.The deflation time was 20 seconds.No additional information was provided.

Manufacturer Narrative

Device codes: 2017 labeled.Internal file number - (b)(4).Correction - reg#.Device code 2017 added: failure to follow steps.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 xpedition, everolimus eluting coronary stent system (eecss), instructions for use, states: prepare an inflation device / syringe with diluted contrast medium.Attach an inflation device / syringe to the stopcock; attach it to the inflation port.With the tip down, orient the delivery system vertically.Open the stopcock to delivery system; pull negative for 30 seconds; release to neutral for contrast fill.Close the stopcock to the delivery system; purge the inflation device / syringe of all air.Repeat steps until all air is expelled.It is unknown if the ifu deviation contributed to the reported event.Additionally, the ifu states: deflate the balloon by pulling negative on the inflation device for 30 seconds.Confirm complete balloon deflation before attempting to move the delivery system.It is likely the ifu deviation contributed to the reported deflation issue.The investigation determined the reported deflation issue appears to be related to the use error, as it was reported and confirmed during follow up with the account that negative pressure was held for 20 seconds in order to deflate the balloon.In addition, there was no damage noted to the stent delivery system (sds) during the inspection prior to use or during preparation for use which suggests a product quality issue did not contribute to the reported difficulties.Further interaction with the moderately tortuous, heavily calcified, 80% stenosed lesion during advancement, as resistance was noted, likely resulted in the reported physical resistance.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 XPEDITION 48 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: 8739471
• MDR Text Key: 149353509
• Report Number: 2024168-2019-05151
• 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,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2022
• Device Catalogue Number: 1070250-48
• Device Lot Number: 9011541
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1