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

Catalog Number 1011709-15

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

Patient Problems Angina (1710); Myocardial Infarction (1969); Heart Failure (2206)

Event Date 06/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event date: (b)(6) 2013: electrocardiogram(ecg); (b)(6) 2013: (ck)=559 u/l, normal upper limit 25; (b)(6) 2013: (ck-mb)=82 ng/ml, normal upper limit 25; (b)(6) 2013: troponin i=1180 ng/l, upper reference limit 14.Concomitant medical device: stent: (2) 2.75x23mm, 3.0x33mm xience prime stents, aspirin, clopidogrel.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The (1) 2.75x23 and 3.0x33mm xience prime stents are filed under separate medwatch report numbers.

Event Description

It was reported that on (b)(6) 2013, a 2.75x23mm, 3.0x15mm, and 3.0x33mm xience prime stents were successfully implanted in the left main (lm) coronary artery lesion to the proximal left anterior descending (lad) and proximal left circumflex (cx) coronary artery lesions.Balloon angioplasty was performed in the marginal coronary artery lesion.A 2.75x23mm xience prime stent was successfully implanted in the mid lad.On (b)(6) 2016, the patient had started experiencing cardiac decompensation and recurrent angina.A myocardial infarction was diagnosed and another percutaneous intervention was performed in the lm, proximal lad, and proximal cx.Medication including ipramol,prednison, antibiotic and diuretics were provided.On (b)(6) 2016, the event resolved without sequela.There was no additional information provided regarding this issue.

Manufacturer Narrative

(b)(4).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 thrombosis is listed in the xience prime everolimus eluting coronary stent systems instructions for use (ifu) 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.However, the treatment appears to be related to the operational context of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the previous medwatch report, the additional information was received: on (b)(6) 2013, a 3.5x28mm, 3.0x15mm, and 3.0x33mm xience prime stents were successfully implanted in the left main (lm) coronary artery lesion to the proximal left anterior descending (lad) and proximal left circumflex (cx) coronary artery lesions.Balloon angioplasty was performed in the intermediate/anterolateral artery and a 2.75x23mm xience prime stent was successfully implanted in the mid lad.On (b)(6) 2016, an st elevated myocardial infarction (stemi) had been diagnosed and thrombosis was noted in the proximal lad.Another percutaneous intervention was performed that day in the proximal left anterior descending (lad), proximal circumflex (cx), and left main (lm) coronary arteries.The event resolved.

Manufacturer Narrative

(b)(4).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.It should be noted that the reported patient effect(s) of angina, myocardial infarction and stenosis are listed in the 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 effect(s), 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: on (b)(6) 2013, a 3.5x28mm (not a 2.75x23mm), 3.0x15mm, and 3.0x33mm xience prime stents were successfully implanted in the left main (lm) coronary artery lesion to the proximal left anterior descending (lad) and proximal left circumflex (cx) coronary artery lesions.A 2.75x23mm xience prime stent was successfully implanted in the mid lad.On (b)(6) 2016, the patient had started experiencing cardiac decompensation, diagnosed as heart failure, and restenosis was noted in all xience prime devices, including the mid anterior descending (lad) coronary, 2.75x23mm xience prime stent.

• 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): 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: 6786800
• MDR Text Key: 82454426
• Report Number: 2024168-2017-06581
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2015
• Device Catalogue Number: 1011709-15
• Device Lot Number: 3011841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• 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): Hospitalization; Required Intervention; Disability
• Patient Age: 62 YR
• Patient Weight: 104