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

Model Number 1550275-28

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

Patient Problems Death (1802); Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Perforation (2001); Respiratory Distress (2045); Shock (2072); Cardiac Tamponade (2226)

Event Date 07/29/2020

Event Type  Death  

Manufacturer Narrative

The device 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 the procedure was to treat a lesion in the proximal left anterior descending artery.A 2.75x28 xience sierra stent was deployed at 12 atmospheres (atms) without issue.Standard post-dilatation with a 3.5x10mm non-abbott cutting balloon was performed at 14 atms.After the inflation, the patient became hypotensive with low cardiac outflow.Via angiogram a perforation at the lesion was noted.Emergent pericardiocentesis was performed.A pericardial drain was placed and used to intermittently remove and auto-transfuse the patient.Patient was placed on levophed drip.Balloon tampanade was attempted with a 3.5x12mm nc trek but the perforation kept leaking.A 2.80x19mm rx grafmaster stent was inserted and deployed at 14 atm.There was still noted leaking into the pericardial space leading to cardiac tamponade.Emergent periocardiocentesis and auto-transfusion were repeated multiple times.After post-dilatation of the covered stent, the perforation seemed to have worsened.Balloon tamponade using a 3.5x12mm nc trek was performed at 18 atm.Once the device was removed, the patient became increasingly hypoxic (lacking oxygen) and was emergently intubated.The nc trek balloon did not cause or contribute to the hypoxia.Additional nc balloons (4x12, 4.5x8) were inflated at 14 atm.Angiography still noted leakage and patient condition worsened.It was decided to then deploy a 4x19mm rx graftmaster at 14 atm as the patient had already entered hemorrhagic shock.The perforation continued to show leakage after the second covered stent implantation.Another 4.5x12mm nc trek balloon was inserted and ballooned at 14 atm, but perforation remained leaking.After post-dilatation of the covered stent, the perforation seemed to have worsened.Patient was emergently taken for coronary by-pass grafting surgery.The patient ultimately died of intramyocardial dissecting hematoma during surgery the same day.An autopsy was not performed.It was confirmed that the use of the nc trek balloons did not cause or contribute to the perforation.No additional information was provided.

Manufacturer Narrative

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 effects of cardiac tamponade, hematoma, hypotension, ischemia, perforation, shock 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.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• Brand Name: XIENCE SIERRA
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10448840
• MDR Text Key: 204218166
• Report Number: 2024168-2020-07067
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227202
• UDI-Public: 08717648227202
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1550275-28
• Device Catalogue Number: 1550275-28
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3.5X10MM WOLVERINE CUTTING BALLOON; 3.5X10MM WOLVERINE CUTTING BALLOON
• Patient Outcome(s): Death
• Patient Age: 75 YR
• Patient Weight: 57