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

Catalog Number 1550225-12

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

Patient Problems Angina (1710); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Thrombosis (2100); Respiratory Failure (2484)

Event Date 12/04/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 effects of death, hypotension, angina, cardio-respiratory arrest, cardiac failure and thrombosis are listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.The other three xience sierra stents referenced are filed under separate medwatch report numbers.

Event Description

It was reported that the procedure was to treat a mildly tortuous and mildly calcified obtuse marginal branch, the diagonal branch and the left anterior descending artery.A 2.25 x 12 mm xience sierra stent was implanted in the obtuse marginal branch, a 2.25 x 18 mm xience sierra stent was implanted in the diagonal branch and a 2.5 x 38 mm xience sierra stent was implanted in the left anterior descending (lad) artery without any issues.However, the patient complained of discomfort and then became hypotensive and experienced cardiac arrest.Therefore, cardiopulmonary resuscitation (cpr) was started and the patient was intubated.It was noted that there was no flow in the vessels that were stented due to thrombus.Therefore, balloon angioplasty was performed in the proximal circumflex, diagonal and lad arteries.Aspiration was performed to remove the thrombus and a 2.5 x 38 mm xience sierra stent was implanted in the distal lad.Cpr continued; however, the patient expired that same day on (b)(6) 2018.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: 8197825
• MDR Text Key: 131466193
• Report Number: 2024168-2018-10045
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227004
• UDI-Public: 08717648227004
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2019
• Device Catalogue Number: 1550225-12
• Device Lot Number: 8072741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2018
• 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
• Patient Outcome(s): Death
• Patient Age: 81 YR
• Patient Weight: 65