MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1500400-28

Device Problems Difficult to Remove (1528); Device Dislodged or Dislocated (2923); Component Misassembled (4004)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/08/2024

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat a heavily calcified, mildly tortuous left anterior descending artery that is 80% stenosed.The vessel was pre-dilated with an non-abbott device.A 3.5 guide was first selected; however did not provide adequate support therefore, a 6fr guideline was used to facilitate the delivery of the stents.An unspecified stent was previously deployed and a 4.0x28mm xience sierra stent delivery system (sds) was advanced too far forward; therefore, was pulled back to reposition to desired location.The sds met resistance with anatomy and the previously implanted stent.The stent partially dislodged and movement of the balloon markers was noted; however, stent was deployed by inflating the delivery system not the intended position in the mid lad layered on the previously implanted stent.A third stent unspecified xience sierra stent was successfully implanted to treat the target lesion at the proximal lad and left main artery.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

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 other incidents from this lot.The investigation determined the reported difficulties related to difficulty to remove (stent and anatomy) and stent dislodgement appear to be related to circumstances of the procedure.The investigation was unable to determine a conclusive cause for the reported component misassembled (marker band misalignment).There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: health effect - impact code 4641 removed.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18820183
• MDR Text Key: 336695948
• Report Number: 2024168-2024-02643
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1500400-28
• Device Lot Number: 3051041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 03/05/2024
• Supplement Dates FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2023
• 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: 6FR GUIDELINE
• Patient Outcome(s): Other