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

Model Number 1550300-38

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Death (1802); No Consequences Or Impact To Patient (2199)

Event Date 11/02/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).Exemption number e2019001.The stent remains in patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

Study patient (b)(6).It was reported that on (b)(6) 2019, a 3.0 x 38 mm xience sierra stent was implanted in the mid right coronary artery (rca).On (b)(6) 2019, the patient died.No additional information was provided.

Manufacturer Narrative

G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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 of death is listed in the xience sierra, everolimus eluting coronary stent systems instructions for use, as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the follow-up # 1 medwatch report, the following information was received: per the study physician, the patient death is not related to the study device or study procedure.Approximately 2 months post procedure, the patient was re-hospitalized with acute respiratory failure, recurrent pleural effusions and hypotension.A chest x-ray and echocardiogram were performed.Right lung thoracentesis was performed and 1.5 liters of fluid were removed.The patient was unable to maintain blood pressure without fluid bolus and her mental status declined.The patient's family opted for comfort care, and on (b)(6)2019 , the patient died.Although the patient death is not related to the implanted xience sierra stent or procedure, this event has been reported; therefore, it will remain reportable.No additional information was provided.

Manufacturer Narrative

An investigation was not conducted because there were no specific reported device malfunctions or patient effects associated with the device.There is no indication of a product quality issue with respect to design, manufacture or labeling.B1, b2, h1: no adverse event or device malfunction occurred as related to the implanted stent h6: patient code 1802 removed device code 2993 removed results code 213 removed conclusions code 22 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
• MDR Report Key: 9454807
• MDR Text Key: 170416095
• Report Number: 2024168-2019-14414
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227301
• UDI-Public: 08717648227301
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2020
• Device Model Number: 1550300-38
• Device Catalogue Number: 1550300-38
• Device Lot Number: 9051641
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Weight: 58