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

Catalog Number 1550225-15

Device Problems Improper or Incorrect Procedure or Method (2017); Physical Resistance (2578); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/08/2018

Event Type  Injury  

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 not returned for analysis.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 similar incidents from this lot.It should be noted that the xience sierra everolimus eluting coronary stent system instruction for use (ifu) states: when treating multiple lesions within the same vessel, stent the distal lesion prior to stenting the proximal lesion.Stenting in this order obviates the need to cross the proximal stent during placement of the distal stent, and reduces the chance of damaging or dislodging the proximal stent.It appears the ifu deviation may have contributed to the reported event.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the previously implanted stent while crossing distally causing the reported physical resistance and subsequent stent dislodgement with the patient effect of foreign body in patient.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was performed to treat a lesion in the chronic total occlusion in the right coronary artery.Two xience sierra stents were successfully implanted in the mid to proximal right coronary artery (rca).The 2.25 x 15 mm xience sierra was advance into the patient anatomy, to treat a diseased portion of the vessel that was distal to the two implanted stents.Resistance was noted advancing through the previously implanted stents; however, the device was able to cross to the target lesion.Once at the target lesion, it was noted that the stent was not on the delivery system.The stent was not seen in the patient anatomy; however, it was felt that the stent was on the delivery system when it was inserted into the patient anatomy.The stent could not be located outside the patient anatomy.A new xience sierra stent was then used to treat the remaining lesion.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: 7626036
• MDR Text Key: 111915223
• Report Number: 2024168-2018-04774
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227011
• UDI-Public: 08717648227011
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2019
• Device Catalogue Number: 1550225-15
• Device Lot Number: 8032641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2018
• 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
• Treatment: XIENCE SIERRA STENTS: 2.25X38, 2.25X28MM
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR