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

Catalog Number 1070250-38

Device Problems Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported that during a procedure of the moderately calcified, non-tortuous, de novo, mid left anterior descending (lad) the xience xpedition stent delivery system (sds) met anatomical resistance and could not cross the lesion.The sds was removed and additional pre-dilatation was completed.While advancing the sds during the additional attempt to cross the lesion the device outside the anatomy at the mid shaft was broken due to anatomical resistance.The procedure was abandoned and the patient was sent for surgical treatment in lieu of percutaneous transluminal intervention (pta).There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned for analysis.The reported shaft detachment was confirmed.The reported failure to advance the device could not be replicated in a testing environment as it was based on operational circumstances.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 xience xpedition everolimus eluting coronary stent system instructions for use states that an unexpanded stent may be retracted into the guiding catheter one time only and 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 may result in stent system damage.The investigation determined the reported difficulties appear to be related to circumstances of the procedure and subsequent use error, as it is likely that as the device was advanced the stent delivery system met resistance with the moderately calcified anatomy resulting in the reported failure to advance.As the device was removed, then re-advanced, resistance with the anatomy resulted in the reported shaft detachment.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE XPEDITION 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
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6863250
• MDR Text Key: 86111747
• Report Number: 2024168-2017-07439
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2020
• Device Catalogue Number: 1070250-38
• Device Lot Number: 6121541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1