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

Catalog Number	1125350-38
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Ventricular Fibrillation (2130); Cardiac Tamponade (2226); Cardiogenic Shock (2262); Respiratory Failure (2484)
Date of Event	01/30/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(6).Case description continued: balloon tamponade was performed via inflation of a 3.5x20mm trek balloon to atm, temporarily stopping the extravasation (with the balloon remaining inflated).An emergent pericardial window was created, the pericardium was successfully drained with placement of a chest tube, the patient was given epinephrine, and the patient stabilized.The 3.5x20mm trek was then deflated and retracted along with the guide wire, an unspecified 35cm 8fr sheath and an 8fr non-abbott gc were advanced via left femoral access, then a 3.5x16mm rx graftmaster covered stent system was advanced to the perforation, across both xience alpine stents, then deployed at 17 atm.As the graftmaster was malapposed, there was still some extravasation.Thus, the graftmaster was post-dilated with a 3.75x15mm nc trek balloon inflated to 20 atm several times for 5-minute durations, ultimately sealing the perforation and concluding the procedure.The femoral artery was closed successfully using a 6fr perclose proglide device.Hypothermia protocol was initiated to address cardiac arrest, the patient was placed in the cardiac intensive care unit (cicu).While in the cicu, epinephrine (10mcg/min) was continued, a large amount of blood passed through the chest tube (suggesting hemorrhage), blood products were transfused, and max doses of epinephrine and phenylephrine were started.Despite vasopressor therapy, hypotension escalated, hemorrhaging continued, and the patient entered ventricular fibrillation arrest.Cpr was administered, but the patient expired hours after the procedure (the same day) due to hemorrhagic shock as a result of the rca perforation with cardiac tamponade.In the opinion of the physician, it is not known if the graftmaster contributed to the aforementioned adverse patient effects and death; it is possible that the perforation site developed recurrent bleeding, but this was not confirmed as an autopsy was not performed.No additional information was provided.(b)(4).Concomitant medical products: guide wire: balance middleweight (bmw) universal 190cm; guiding catheter: 6fr al1; turnpike spiral catheter; 5.5fr guideliner; stent: 3.0x38 xience alpine.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.A cine was received and reviewed by an abbott vascular clinical specialist who noted the following: the xience alpine deployment causing the perforation was not included in the imaging.The reported patient effects of cardiac arrest, death, hemorrhage, hypotension, perforation, ventricular fibrillation, cardiac tamponade, respiratory failure, are listed in the xience alpine everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The rx graftmaster 3.5x16 device referenced is being filed under a separate manufacturing report number.
Event or Problem Description
It was reported that the procedure was to treat a chronic total occlusion (cto) in the mid right coronary artery (rca).Multiple dilatations were performed and a 3.0x38 xience alpine crossed and was deployed at 11 atmospheres (atm), followed by post-dilatation to 18 atm.A 3.5x38mm xience alpine was then advanced and deployed at 11atm, proximally overlapping the 1st stent then post-dilated to 18atm.A post-stent angiogram revealed a large free perforation of the mid rca with extravasation into the pericardium that was reportedly caused by the 3.5x38 (not the 3.0x38) xience alpine stent.Reportedly, there were no other device issues or adverse patient effects related to the 1st implanted 3.0x38mm xience alpine stent.The patient developed pulseless electrical activity (cardiac arrest), requiring cardiopulmonary resuscitation (cpr) and intubation.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6360969
• Report Number: 2024168-2017-01575
• Device Sequence Number: 675858
• Product Code: NIQ
• UDI-Device Identifier: 08717648199578
• UDI-Public: (01)08717648199578(17)191108(10)6110141
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/27/2017

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: 11/08/2019
• Device Catalogue Number: 1125350-38
• Device Lot Number: 6110141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2017
• Initial Report FDA Received Date: 02/27/2017
• 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: 84 YR
• Patient Weight: 74