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

Catalog Number 1550225-23

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Material Deformation (2976); Material Too Soft/Flexible (4007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2018

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 customer reported the device was discarded.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 performed to treat a lesion in the mid to distal left anterior descending coronary artery with moderate tortuosity, moderate calcification and 90% stenosis.Following pre-dilatation, a 2.25x23 mm xience sierra stent delivery system (sds) was advanced, but failed to cross the lesion due to resistance with the patient anatomy.The sds was removed with resistance from the lesion and further pre-dilatation was done.The sds was re-advanced; however, it was noted that the support from the delivery system had changed and the sds was removed when resistance with the anatomy was met.Post removal from the anatomy with resistance, the distal tip of the sds was noted to be flared.A non-abbott stent was used successfully to complete the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.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.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 or dislodged during retraction back into the guiding catheter.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 other similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure and subsequent deviation of the ifu as it is likely that the stent delivery system met resistance with the moderately tortuous, moderately calcified and 90% stenosed anatomy resulting in the reported failure to advance.As the device was reinserted (against the ifu) interaction with the moderately tortuous, moderately calcified and 90% stenosed anatomy and/or other devices resulted in the reported tip collapse/damage thus resulting in the reported change in support of the device.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initially filed report, the following information was received: it was inadvertently reported that there was resistance on removal of the 2.25x23 mm xience sierra stent delivery system (sds).There was no resistance with the anatomy during removal of the sds after either the first or second advancement.No additional information was provided.

• 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
• 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: 7856261
• MDR Text Key: 119651011
• Report Number: 2024168-2018-06958
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2021
• Device Catalogue Number: 1550225-23
• Device Lot Number: 8032341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2018
• 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