MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Model Number 1550300-38

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

Patient Problems Dyspnea (1816); Hypoxia (1918); Myocardial Infarction (1969); Neurological Deficit/Dysfunction (1982); Tachycardia (2095); Stenosis (2263); Heart Failure/Congestive Heart Failure (4446)

Event Date 09/28/2020

Event Type  Injury  

Manufacturer Narrative

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

Patient id: (b)(6).It was reported that the procedure was performed on (b)(6) 2019, to treat a target lesion in the heavily calcified mid left anterior descending (lad) artery.The 2.75 x 38 mm xience sierra stent was implanted, treating the target lesion.On (b)(6) 2020, the patient began to experience shortness of breath (sob) and presented to the emergency department with sob, tachycardia, hypoxia and altered mental status.The patient was placed on bilevel positive airway pressure (bipap), and the patient¿s condition improved with oxygenation.Electrocardiogram noted changes and troponin levels were elevated.In-stent restenosis of 90% was noted in the proximal lad.The patient was admitted to the cath lab with st elevation myocardial infarction equivalent.Two drug eluting stents were implanted in the proximal lad, and three additional drug eluting stents were implanted in the proximal to mid right coronary artery (rca).No additional information was provided.

Manufacturer Narrative

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 effects of stenosis and myocardial infarction 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

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.Na.

Event Description

Subsequent to the final mdr, additional information was provided.The patient was re-hospitalized with elevated right heart pressure with significant volume overload [heart failure].The patient was placed on bilevel positive airway pressure (bipap), and the patient¿s condition improved with oxygenation, and later weaned to room air.Intervention was performed to treat restenosis in the left anterior descending artery and the patient condition resolved on (b)(6) 2020.No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10744358
• MDR Text Key: 213467509
• Report Number: 2024168-2020-08947
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227301
• UDI-Public: 08717648227301
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2020
• Device Model Number: 1550300-38
• Device Catalogue Number: 1550275-38
• Device Lot Number: 9021141
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 29 YR
• Patient Weight: 61