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

Model Number 1074400-18

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

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Occlusion (1984)

Event Date 01/23/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).The stent remains in patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The 2.5x30 trek and 2.5x38 xience xpedition referenced are being filed under separate medwatch report numbers.

Event Description

It was reported that the 2.5x30 mm trek dilatation catheter was inflated three times in the calcified mid left anterior descending (lad) coronary artery.It was inflated at 14 atmospheres (atms), 20 atms and 18 atms when the trek ruptured.During removal of the trek, the balloon separated and remained in the artery.Attempts made to remove/snare out the separated segment of the trek were not successful.A vessel perforation occurred in the mid lad during use of a non-abbott dilatation catheter, but the patient remained stable.The 2.5x38 mm xience xpedition stent was deployed at 12 atms for 15 sec, then 12 atm for 22 sec, then 20 atm for 15 sec, and 5 atm for 11 sec in the mid lad over the separated trek balloon; however, the stent delivery system (sds) did not fully deflate and was difficult to remove from the guide catheter, so the sds and guide catheter were removed together as a unit.The patient remained stable.A 3.5x38 mm xience xpedition stent was implanted in the proximal lad and a 4.0x12 mm xience xpedition stent was implanted in the ostial left main coronary artery.A 4.0 x 18 mm xience xpedition stent was implanted in the predilated left main to left circumflex.After post dilatation of the 4.0x18 mm xience xpedition stent using a non-abbott dilatation catheter, the blood pressure dropped and cardiac arrest occurred.There was no reflow in the lad.The patient was ventilated and three doses of epinephrine were administered, but the blood pressure was gone.No further attempts to resuscitate the patient were performed because the patient was a do not resuscitate.The patient expired.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 hypotension, occlusion and death are listed in the xience xpedition everolimus eluting coronary stent systems 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, it should be noted that a medical review was performed by an abbott vascular clinical specialist who concluded the xience xpedition des 4.00x18 rx was not directly related to the patient¿s death.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• Brand Name: XIENCE XPEDITION
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9707781
• MDR Text Key: 179313373
• Report Number: 2024168-2020-01473
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648162640
• UDI-Public: 08717648162640
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/29/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2022
• Device Model Number: 1074400-18
• Device Catalogue Number: 1074400-18
• Device Lot Number: 9090441
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/13/2020
• Supplement Dates Manufacturer Received: 04/17/2020
• Supplement Dates FDA Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DILATATION CATHETERS: 4.0X15 SPRINTER; XIENCE XPEDITION (2.5X38, 3.5X38, 4.0X12); DILATATION CATHETERS: 4.0X15 SPRINTER; XIENCE XPEDITION (2.5X38, 3.5X38, 4.0X12)
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Weight: 48