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

Catalog Number 1120275-33

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

Patient Problems Angina (1710); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Pericardial Effusion (3271)

Event Date 06/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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.It should be noted that the reported patient effect(s) of angina, hypotension and arterial perforation are listed in the xience alpine instructions for use (ifu) as a known patient effect(s) of coronary stenting procedures.A conclusive cause for the reported patient effect(s), 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.The hi-torque turn trac guide wire referenced is filed under a separate manufacturing report number.

Event Description

It was reported that this was a percutaneous intervention treating the right coronary artery and the left circumflex (lcx) coronary artery, moderately calcified lesion.The ht turntrac guide wire was advanced to the lcx without reported issue and pre-dilatation was performed.Two xience alpine stents were implanted in the proximal lcx (2.75x33mm and 3.0x12mm xience alpine stents).Following, a perforation was noted at the distal end of the 2.75x33 xience alpine stent.A 2.5x12mm xience alpine stent was implanted as treatment for the perforation.Per imaging, there was no pericardial effusion seen following.The patient's condition, however, had worsened as evident by a drop in blood pressure, chest pain, and shortness of breath.Following a second evaluation, a pericardial effusion was confirmed.A pericardial puncture was performed, removing 500ml of blood and the perforation was covered using a non abbott stent.Medications were possibly provided in addition.Per physician, it is assumed that the ht turntrac caused the perforation.The patient is in stable condition.No additional information was provided regarding this issue.

• Brand Name: XIENCE ALPINE 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 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: 7701065
• MDR Text Key: 114405565
• Report Number: 2024168-2018-05598
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2021
• Device Catalogue Number: 1120275-33
• Device Lot Number: 8011341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2018
• 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): Required Intervention