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

Catalog Number 1550300-15

Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The stent remains in 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 performed to treat a concentric lesion in the mid left anterior descending (lad) coronary artery with mild tortuosity, heavy calcification and 90% stenosis.Following pre-dilatation, a 3.00 x 15 mm xience sierra stent delivery system (sds) was advanced but failed to cross the lesion and was removed.A 4.5f non-abbott guide catheter was placed and the sds was attempted to be re-advanced; however, the sds could not be inserted into the guide catheter.The guide catheter was switched to a 6f catheter and the sds was advanced again.The sds crossed the lesion against resistance from the anatomy and reached the distal lad.On an attempt to pull the sds back to the target lesion, resistance with the anatomy was met and the stent dislodged in the distal lad.The stent was ultimately deployed at the distal lad with two balloon catheters.An additional xience stent was successfully deployed to treat the target lesion.There was no reported adverse patient sequela and the patient was discharged from hospital.No additional information was provided.M.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.It should be noted that the xience sierra, everolimus eluting coronary stent system (eecss), 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 dislodge during retraction back into the guiding catheter.In addition, it should be noted that the eecss chipboard box label specifies that the minimum guiding catheter compatibility for a 3.0x15 mm diameter xience sierra stent is 5f (0.056 inch) inner diameter.In this case, it is unknown if the ifu deviations directly caused or contributed to the reported difficulties.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.The investigation determined the reported difficulties and subsequent treatments appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• 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: 8220276
• MDR Text Key: 132196466
• Report Number: 2024168-2019-00095
• 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: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2021
• Device Catalogue Number: 1550300-15
• Device Lot Number: 8030441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2018
• 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
• Patient Outcome(s): Required Intervention