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

Catalog Number 1009539-28

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

Patient Problems Angina (1710); Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Respiratory Distress (2045)

Event Date 08/25/2011

Event Type  Death  

Event Description

It was reported that the patient had unstable angina and on (b)(6) 2011 percutaneous coronary intervention (pci) was performed to the 90% stenosed, heavily calcified, de novo left main (lmt#5) to left anterior descending (lad#6) and to the 90% stenosed, heavily calcified, de novo bifurcation circumflex (lcx#11).After pre-dilatation, a 2.5 x 28 mm non-abbott stent was placed at a lesion in the lad# 6.A 3.0 x 23 mm xience v stent was placed at a lesion from the lmt#5 to lad#6.The stent of the xience v was expanded using the sds balloon; the 2.5 x 28 mm non-abbott stent was placed from the lmt to lcx.A kissing balloon technique (kbt) was performed at the lmt to lad and lcx.Post dilatation with an unspecified device was performed at lad#6.Intravascular ultrasound (ivus) was performed and the procedure was completed without issue.On (b)(6) 2011, pci was performed to a 90% stenosed, bifurcation, diffused, tortuous, de novo lesion in lcx#12 after pre-dilatation and ivus, a 2.75 x 24 mm non-abbott stent was placed at the lesion.Ivus was performed and the procedure was completed without issue.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.On (b)(6) 2011, pci was performed to a 100% stenosed, heavily calcified, de novo lesion in rca#2.After pre dilatation and ivus, a 2.5 x 24 mm non-abbott stent and a 2.5 x 28 mm xience v stent were placed at the lesion.During the procedure, the patients blood pressure decreased and bradycardia developed.Atropine sulfate medication was administered.The blood pressure was temporarily improved, but the blood pressure gradually diminished and the patients breathing decreased.A respirator was placed and a intra-aortic balloon pump (iabp) was inserted in the anatomy.Angiography to the left coronary artery revealed thrombotic shadow and 99% stenoses at the lmt, lad, and lcx where the stents were placed, but not at the rca.Argatroban medication was administered to treat the stent thrombosis as heparin-induced thrombocytopenia (hit) was suspected.Percutaneous cardiopulmonary support (pcps) could not be inserted.The patients blood pressure decreased and the patient expired.No additional information was provided.Concomitant medical products: stent: 2.5 x 28 mm nobori; 2.75 x 24 mm nobori; 2.5 x 24 mm nobori; 3.0 x 23mm xience v.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The other xience v referenced, is being filed under a separate manufacturing report number.

Manufacturer Narrative

(b)(4).There was no reported device malfunction and the product was not returned.The reported patient effects of angina, bradycardia, hypotension, death, and respiratory distress, as listed in the xience v everolimus eluting coronary stent system instructions for use (ifu) are known patient effects that may be associated with the use of the device.Although 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 deficiency with respect to manufacturing, design or labeling.

• Brand Name: XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4219779
• MDR Text Key: 5061933
• Report Number: 2024168-2014-07168
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1009539-28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 77 YR
• Patient Weight: 53