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

Catalog Number 1550275-33

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stenosis (2263); Test Result (2695)

Event Date 07/02/2019

Event Type  Injury  

Manufacturer Narrative

The stent remains in patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.(b)(4).

Event Description

Study patient id: (b)(6).It was reported that on (b)(6) 2018, a 2.75x33mm xience sierra stent was implanted in the mid left anterior descending (lad) coronary artery lesion.An abnormal stress tests occurred following a scheduled follow-up.On (b)(6) 2019, percutaneous catheterization was performed and in-stent restenosis of the 2.75x33mm xience sierra stent was observed.There was no device malfunction.As treatment, another stent was implanted in the mid lad.The event resolved.No additional information was provided regarding this issue.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect(s) of stenosis is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.Exemption number e2019001.

• Brand Name: XIENCE SIERRA
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8837203
• MDR Text Key: 152517699
• Report Number: 2024168-2019-10420
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227219
• UDI-Public: 08717648227219
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2019
• Device Catalogue Number: 1550275-33
• Device Lot Number: 8071141
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 67