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

Catalog Number UNK XIENCE SIERRA

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Non specific EKG/ECG Changes (1817); Thrombosis (2100); Diaphoresis (2452)

Event Date 06/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the 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 to treat a stenotic mid right coronary artery.Prior to the initial procedure, the patient presented with shortness of breath.An unspecified xience sierra stent was implanted at the lesion without any complications.An hour later, the patient was noted with showing symptoms of st-changes in electrocardiogram (ekg) and was diaphoretic (sweating).In-stent thrombosis was confirmed through angiography.It was also noted through cine images that the stent was not fully apposed to the vessel wall.Thrombectomy followed by balloon angioplasty were performed as treatment.Patient outcome was very good.No additional information was provided.

Manufacturer Narrative

(b)(4).No udi is being reported because the part and lot number were not provided.The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot numbers were not provided.The reported patient effects of thrombosis is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported difficulty to deploy (wall apposition) with the patient effects of ekg, thrombosis and diaphoresis.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 7634024
• MDR Text Key: 112181826
• Report Number: 2024168-2018-04927
• Device Sequence Number: 1
• Product Code: NIQ
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/16/2018

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: UNK XIENCE SIERRA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2018
• Initial Date FDA Received: 06/25/2018
• Supplement Dates Manufacturer Received: 07/11/2018
• Supplement Dates FDA Received: 07/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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