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

Catalog Number 1125250-38

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

Patient Problems Cardiac Arrest (1762); Myocardial Infarction (1969); Thrombosis (2100)

Event Date 12/03/2017

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 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 mildly tortuous, non-calcified concentric lesion in the distal left anterior descending coronary artery.On (b)(6) 2017, a 2.50 x 38 mm xience alpine stent was implanted at the lesion for angina pectoris.On (b)(6) 2017, the patient experienced myocardial infarction (mi) which led to stent thrombosis, within 5 mm either side of and including the stent margin, being discovered.The patient suffered a cardiac arrest following mi.Angiography and intravascular ultrasound confirmed the thrombosis.A 3.0 x 28 mm xience alpine stent was implanted in the same lesion.The patient remains hospitalized.No additional information was provided.

Manufacturer Narrative

(b)(4).Type of reportable event changed from serious injury to death.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 death, renal failure, myocardial infarction, and thrombosis are listed in the xience alpine, everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effect(s), 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 initially filed mdr, additional information was attained.Intravascular ultrasound (ivus) was performed after implantation of the 2.5 x 38mm xience alpine stent and no issue was observed.After treatment of the thrombosis, the patient experienced cardiac arrest following mi and then developed renal failure which ended up with multiple organ failure (mof).On (b)(6) 2017, the patient died.An autopsy was not performed.A decision was made that a causal relationship between the xience alpine and the patients death is unknown but that the device did not cause the circumstances of the event.

• Brand Name: XIENCE ALPINE 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: 7131101
• MDR Text Key: 95318542
• Report Number: 2024168-2017-09930
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2020
• Device Catalogue Number: 1125250-38
• Device Lot Number: 7082541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 01/24/2018
• Supplement Dates FDA Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• 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; Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 62