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

Catalog Number 1500325-38

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

Patient Problems Angina (1710); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Nausea (1970); Thrombosis (2100)

Event Date 06/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Description of problem or event (continued): on (b)(6) 2018, the patient had severe lv systolic dysfunction with a total occlusion of the lad and diagonal.Thrombectomy was performed within the lad.This resulted in improved flow and definite extraction of thrombus.Additional high-pressure ballooning was performed on both the lad and diagonal arteries.At the conclusion of the procedure, timi 3 flow was present in both vessels, although there was still moderate ostial disease in the diagonal and mild ostial disease in the lad.The physician requested that the patient stop taking brilinta with plans to revascularize later that week.The patients ejection fraction on his lv gram was poor, probably in the range of 15%.On (b)(6) 2018, after holding the patients brilinta for several days the patient underwent coronary artery bypass surgery.The left internal mammary artery was used to bypass the lad branch and reverse saphenous vein graft was used to bypass the diagonal branch.The patients postoperative course was quite unremarkable with the exception that the patient required multiple drips for multiple days for management of congestive heart failure (hypotension).The patient had a prolonged stay in the intensive care unit so that all of the drips could wean down and off.The patient continues to be on core measure medications including beta-blockers, act inhibitors, statin therapy, and aspirin.The patients blood pressure is borderline at 90-100 systolic; however, the patient is tolerating it well.The patient was discharged on (b)(6) 2018.On (b)(6) 2018, the patient started having swelling of the right arm and that has been getting worse and started having pain.The patient was evaluated in the er and venous doppler of right upper extremity showed extensive clots from the right ij to axillary to subclavian vein into basilic vein.The patient was admitted to the hospital and was put on lovenox, which improved the swelling.The patient was changed over to oral eliquis and tolerated it well.The patient will need eliquis treatment for three months, as this was provoked deep vein thrombosis.The patient is doing well, the right arm swelling subsided and has no pain.The patient was discharged on (b)(6) 2018.On (b)(6) 2019, a pacemaker was implanted.No additional information was provided.Concomitant medical products: guide wire: bmw universal, runthrough, prowater, guide catheter: xb 3.5, jl4 5f, jl4 7f, sheath: cordis 6f.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 on (b)(6) 2018, the patient presented with chest pain.A 3.0x20mm non-abbott drug-eluting stent (des) was implanted in a 100% occlusion in the proximal left anterior descending artery (lad) where unspecified stents had been previously deployed.On (b)(6) 2018, the patient presented to the emergency room (er) with severe chest pain radiating down the left arm.Post-aspiration following thrombectomy, an angiogram showed return of timi 3 flow with residual stenosis in the mid lad.A 3.25x23mm xience sierra stent delivery system (sds) was advanced; however, it was removed undeployed for unknown reasons.A 3.25x38mm xience sierra was implanted from the mid lad just distal to the ostium of the diagonal artery.Post-stent deployment angiogram showed timi 3 flow.The stent was well expanded and well opposed.The patient was also noted to be hypotensive during the procedure, hence was started on dopamine.No complications were witnessed during the procedure.The patient was transferred to the intensive care unit for close monitoring.The patient was nauseous in the er, as well as during the catheterization.On (b)(6) 2018, the patient presented in the er with chest pain and was emergently sent to the cardiac catheterization laboratory for presumed occlusion of the lad stent.The patient has been on antiplatelet therapy but has failed medical therapies on several occasions.

Manufacturer Narrative

Internal file number - (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 effect of angina, hypotension, nausea and thrombosis are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a 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.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.

Manufacturer Narrative

Patient codes: 1969 labeled.Internal file number - (b)(4).The reported patient effect of myocardial infarction is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.Attachment: user facility medwatch (mw5086885).

Event Description

Subsequent to the previously filed report, additional information was received: user facility medwatch (mw5086885) report received that states: had a heart attack, then had another one on 2018, then another one on 2018 that led to open heart surgery on 2018, then they just put in a defibrillator on 2019 due to the stent.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
• MDR Report Key: 8692706
• MDR Text Key: 147777149
• Report Number: 2024168-2019-04639
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1500325-38
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10 FOR CONCOMITANT MEDICAL DEVICES
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 54 YR
• Patient Weight: 76