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

Model Number	1550350-28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)
Date of Event	07/21/2021
Type of Reportable Event	Death
Additional 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.Based on the information reviewed, there is no indication of a product quality issue.The reported patient effects of hypotension, perforation and death are listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic 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; however, the reported 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 or Problem Description
It was reported that this was a percutaneous coronary intervention in the left anterior descending (lad) coronary artery.This patient was a prohibitive risk for any surgical intervention.At the beginning of the coronary procedure, an impella device was placed.Orbital atherectomy was performed in the lad.The 3.5x28 mm xience sierra stent was deployed at nominal pressure.A non-compliant 4.0 balloon dilatation was inflated to 16 atmospheres and resulted in a perforation in the mid segment of the xience stent.Balloon tamponade and emergent pericardiocentesis were performed to stabilize the patient.Epinephrine pushes were administered to maintain blood pressure along with aggressive hydration.The patient was moving and was thus paralyzed and intubated for safety reasons.The 3.5x19 mm graftmaster stent was implanted in the distal segment of the xience stent and inflated to 20 atmospheres.There was inadequate wall apposition of the graftmaster with evidence of continued perforation and extravasation.A non-compliant balloon was inserted, but was unable to be delivered.The guide catheter was replaced with another guide catheter.A guide liner was inch-wormed into the mid lad.A 4.0 mm nc balloon was able to perform post dilatation of the graftmaster at nominal pressure.There continued to be extravasation of blood into the pericardium due to the malapposed proximal part of the graftmaster.A 4.0x38 mm xience sierra stent was placed in overlapping fashion to the graftmaster stent.The overlapped segment was postdilated and the perforation was sealed.The patient was started on an epinephrine drip, dobutamine drip, and phenylephrine drip with boluses of phenylephrine.Aggressive hydration and three units of blood transfusions were administered along with bicarbonate, magnesium, and potassium.The cause of the patient's low blood pressure was unable to be identified.Due to the poor prognosis, the patient's family decided to remove him from the ventilator and the impella device.The patient expired shortly after from cardiac arrest.An autopsy was not performed.No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12304613
• Report Number: 2024168-2021-07057
• Device Sequence Number: 3971260
• Product Code: NIQ
• UDI-Device Identifier: 08717648227448
• UDI-Public: 08717648227448
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/15/2022
• Device Model Number: 1550350-28
• Device Catalogue Number: 1550350-28
• Device Lot Number: 006024C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 57 YR
• Patient Weight: 55