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

Catalog Number 1011734-18

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

Patient Problems Angina (1710); Death (1802); Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132); Cardiogenic Shock (2262); Stenosis (2263)

Event Date 11/27/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the anatomy.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that, on (b)(6) 2013, a 3.5x18mm xience prime stent was successfully implanted in the distal right coronary artery (rca).On (b)(6) 2017, stenosis was noted in the mid to distal rca.There was restenosis of the xience prime stent with recurrent myocardial ischemia.On (b)(6) 2017, the patient was hospitalized for target lesion revascularization.On (b)(6) 2017, dilatation was performed in the mid and distal rca, 90% stenosed lesions.A non-abbott stent was implanted in the mid rca and a new bypass graft was planned for the distal rca.Post stent implantation in mid rca, blood flow through the vessel became slow.The patient experienced chest pain, no blood flow was noted, and blood pressure dropped.Ventricular tachycardia occurred treated with adrenaline.Blood pressure and heart rate improved temporarily.Ventricular fibrillation occurred and cardiopulmonary resuscitation was performed.Spontaneous circulation temporarily returned and a temporary external pacemaker was started.An attempt was made to place a bypass graft in the distal rca; however, this failed due to heavy arteriosclerosis.An emergent thoracotomy was performed and cardiac massage was performed.A reverse vessel was inserted into the ascending aorta and an oxygenator pump (intra-aorta balloon pump) was started.Spontaneous circulation did not return and further circulator maintenance was considered difficult.The patient expired due to cardiogenic shock.No autopsy was performed.There was no additional information provided.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The reported patient effects of angina, hypotension, ischemia, ventricular fibrillation, ventricular tachycardia and stenosis are listed in the xience prime, xience prime everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect(s) of coronary stenting procedures.A conclusive cause for the reported patient effects 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.

Event Description

Subsequent to the initial medwatch report, the additional information was obtained: a coronary artery bypass graft was not attempted to be placed.

• Brand Name: XIENCE PRIME 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: 7168749
• MDR Text Key: 96519302
• Report Number: 2024168-2018-00105
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1011734-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2018
• 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
• Treatment: PYRINE
• Patient Outcome(s): Death
• Patient Age: 70 YR
• Patient Weight: 55