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

Catalog Number 1550250-23

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Angina (1710); Myocardial Infarction (1969); Thrombosis (2100)

Event Date 01/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Event description (continued): therefore, a 2.5x23mm xience sierra stent was deployed overlapping the proximal portion of the previously implanted xience xpedition stent for treatment of the occlusion.Argatroban was administered intracoronary and although thrombus had continued to increase at 5 minutes and 10 minutes later, blood flow was maintained, and the index procedure concluded.The patient remained in the hospital, and on (b)(6) 2019, the patient presented with chest tightness.Electrocardiograph (ecg) showed stemi and angiography confirmed thrombotic occlusion.Dilatation was performed with a 2.5mm balloon, and blood flow was restored; however, in-stent thrombosis was noted.Thrombus aspiration was performed twice, and imaging showed additional thrombus in the location where the previously implanted xience stents overlapped, and it was noted that the stent struts were not fully apposed in that location.Dilatation was performed at high pressure in the two previously implanted xience stents to treat the thrombus; however, imaging later showed that the thrombus had increased, and therefore iabp was inserted and thrombus was alleviated.The procedure was subsequently completed, and the patient remained hospitalized.The patient was assessed as recovered on (b)(6) 2019 and later discharged from the hospital on (b)(6) 2019.The reporting physicians opinion indicates that the 2.5x23 mm xience sierra was dilated at a low pressure (10 atm) in the 3.0x48 mm xience xpedition stent in an overlapping manner.The 2.5x23 mm xience sierra stent was not fully apposed to the vessel wall.Additionally, the anti-platelet therapy could not affect sufficiently.These factors could have contributed to the thrombotic occlusion.No additional information was provided.The xience xpedition device referenced is being filed under a separate medwatch report.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) 2019, a procedure was performed to treat a lesion in the proximal right coronary artery (rca).The patient presented with st-elevated acute myocardial infarction (stemi) and cardiogenic shock.Pre-dilatation was performed with a 2.5mm balloon, and air or thrombus was noted in the mid rca.A thrombus aspiration catheter was advanced, but did not cross to treat the thrombus, thus additional balloon dilatation was performed.An intravascular ultrasound (ivus) catheter was then advanced and showed a long range of plaque.A 3.0x48mm xience xpedition stent was then deployed without reported issue in the rca; however, blood flow was slightly slow in the rca and poor in the posterior descending branch.An ivus catheter showed that the vessel diameter was narrow due to shrinkage and plaque, and that the xience xpedition stent was not fully apposed in the mid and proximal portions.Subsequently, post-dilatation was performed with 2.5mm and 3.5mm balloons in the mid and proximal stent portions, respectively.An intra-aortic balloon pump (iabp) was then inserted; however, the procedure could not be concluded as angiography showed an occlusion in the proximal rca.Baby aspirin and effient (prasugrel) were administered twice and balloon angioplasty with a 2.5mm balloon was performed to treat the occlusion; however, the occlusion reappeared 10 minutes later.Additional dilatation was performed and cilostazol medication was administered as treatment; however, thrombus was noted, and blood flow slowed.

Manufacturer Narrative

Internal file number - (b)(4).The device was not returned for analysis.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded that in the setting of thrombotic acute mi intervention, stent under-sizing and stent strut mal-apposition contributed to repeated stent thrombosis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined the reported difficult to deploy appears to be related to circumstances of the procedure, as it is likely that under-sizing of the vessel and plaque in addition to interaction with the previously implanted stent contributed to the reported difficulty deploying the stent (wall apposition).The reported patient effects of angina, myocardial infarction and thrombosis are listed in the xience sierra, everolimus eluting coronary stent system, 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.

Event Description

Subsequent to the initial report, additional reported information indicates that on (b)(6) 2019 the patient presented with chest tightness for which byaspirin 100mg and efient (prasugrel) 10 mg were administered twice orally.On (b)(6) 2019and (b)(6) 2019 respectively, brilinta (ticagrelor) and xarelto (rivaroxaban) medications were administered.Brilinta was discontinued on an unknown date and xarelto was discontinued on (b)(6) 2019.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: 8345177
• MDR Text Key: 136333570
• Report Number: 2024168-2019-01157
• 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: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2021
• Device Catalogue Number: 1550250-23
• Device Lot Number: 8022141
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STENT: 3.0X48MM XIENCE XPEDITION; STENT: 3.0X48MM XIENCE XPEDITION; STENT: 3.0X48MM XIENCE XPEDITION; STENT: 3.0X48MM XIENCE XPEDITION
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 51 YR
• Patient Weight: 66