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

Catalog Number 1076300-28

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Cardiac Arrest (1762); Death (1802); Myocardial Infarction (1969); Thrombosis (2100); Ventricular Tachycardia (2132)

Event Date 07/31/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).Concomitant products: stent: biomatrix 2.5x36mm; other: abbott implant 3.5x18mm.(b)(4).It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.The investigation was unable to determine a conclusive cause for the reported patient effects however the difficulty deploying the stent and treatments appear to be related to circumstances of the procedure.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The reported patient effects of death, myocardial infarction, thrombosis, and ventricular tachycardia, as listed in the xience pro x everolimus eluting coronary stent system instructions for use (ifu) are known patient effects that may be associated with use of a coronary stent in native coronary arteries.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 the design, manufacture or labeling of the device.The xience prox is currently not commercially available in the u.S.; however, it is similar to a device sold in the u.S.

Event Description

It was reported that the procedure on (b)(6) 2015 was to treat a patient presenting with a st elevated myocardial infarction (stemi).Angiogram revealed a thrombosis in the mid circumflex (cx) and complete closure of the proximal left anterior descending artery (lad).The lad was pre-dilated with a 2.5x30mm balloon and a 2.5x36mm non-abbott was deployed in the mid lad.A 3.0x28mm xience prox was deployed in the proximal lad.Post-dilatation was done in the proximal end of the xience prox stent with a 3.0x12mm nc trek.Optical coherence tomography (oct) and angiogram showed good results but a slight malappostion of the xience prox stent remained as well as a plaque protrusion.The cx was then pre-dilated with a 3.5mm nc trek.A 3.5x18mm implant was deployed at 12 bar, followed by post-dilatation with a 3.5mm nc trek.Good results on oct and angiogram; residual stenosis of 0%.On (b)(6) 2015, the patient returned with a stemi and angiogram revealed thrombosis in all three implants placed in the index procedure.Several balloon dilatations were performed with a 3.0mm nc trek in the cx and lad.The patient became haemodynamically unstable with ventricular and subventricular tachycardia.The patient received amiodaron, arterenol infusion, dobutamin and supra.Several defibrillations were done and at the end asystole and cpr.Patient was transferred to intensive care for implantation of an extracorporeal membrane oxygenation unit.The patient died shortly after.The physician felt the thrombosis was related to dual antiplatelet therapy (dapt) non-compliance, but it could not be confirmed whether or not the patient had been compliant with dapt.

Manufacturer Narrative

(b)(4).A cine of the procedure was returned and reviewed by abbott vascular clinical specialist.The reviewer concluded regarding the index procedure on (b)(6) 2015 that there was successful recanalization of a totally occluded left anterior descending (lad) using two metallic stents.Despite recanalization flow to the distal vessel is compromised and there was some obstruction to the 1st diagonal branch due to stent jail.After pre-dilatation there was successful implantation of an implant in the mid circumflex (cx).The implant was post-dilated, but follow-up images may show under expansion of the implant.Regarding the procedure on (b)(6) 2015, the reviewer concluded thrombotic occlusion of the mid lad and prox cx is seen at the level of previous interventions.Plain old balloon angioplasty (poba) was used to re-expand both stents in lad and the implant in the cx.In both cases flow to the distal vessel was improved.It was reported that the patient in this case may not have been compliant with dapt which may have contributed to this event.

• Brand Name: XIENCE PROX EVEROLIMUS ELUTING RX 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 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5011093
• MDR Text Key: 23333129
• Report Number: 2024168-2015-04710
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2018
• Device Catalogue Number: 1076300-28
• Device Lot Number: 5041041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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