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

Catalog Number 1011710-38

Device Problems Detachment Of Device Component (1104); Deflation Problem (1149); Difficult to Remove (1528)

Patient Problems Angina (1710); Death (1802); Fever (1858)

Event Date 02/05/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the patient had been experiencing chest pain for one year.The procedure was to treat a mid left anterior descending artery that was 90% stenosed.A 3.5 x 38 mm xience prime stent delivery system (sds) was advanced and inflated to 12 atmospheres; however, there was resistance during attempted withdrawal because the balloon did not deflate.An attempt was made to deflate the balloon by puncturing it with a guide wire but it failed.The balloon finally broke into two pieces in the anatomy.The patient experienced chest pain and fever and was transferred to another hospital for emergency coronary artery bypass surgery (cabg).The stent delivery system was removed post-operatively through thoracotomy.The patient expired after surgery the same day.The cause of death is unknown.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned for analysis.The reported detachment of a device component was confirmed.The reported deflation issues and difficulty to remove could not be confirmed as the device condition prevented any functional testing from being performed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded it is noted within the images provided that the stent system balloon used to treat the proximal lad did not fully deflate.It appears that the distal end of the stent system is irregularly shaped.The initial inflation was done at 15:50.The last image received was timed at 16:25.This means that the balloon was partially inflated in the proximal lad for a minimum of 35 minutes.It is seen that attempts were made to re-inflate and deflate the balloon.The reported patient effects of angina, fever and death are listed in the xience prime, everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported deflation issues; however, the difficulty to remove and detachment of a device component with the patient effects of angina appear to be related to operational context of the procedure.Additionally, the investigation was unable to determine a conclusive cause for the reported patient effects of fever and death, and the relationship to the device, if any.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE PRIME LL 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: 7307603
• MDR Text Key: 101311526
• Report Number: 2024168-2018-01488
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2020
• Device Catalogue Number: 1011710-38
• Device Lot Number: 7061241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• 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