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

Catalog Number 1128350-38

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 09/22/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.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 other incidents from this lot.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the device met resistance with the guide wire and guide catheter during removal causing the reported difficulty to remove.The balloon separated from the stent delivery system during the difficult removal resulting in the reported material separation.The reported hypertension and treatments appear to be related to operational context of the procedure.The reported patient effect of hypertension is listed in the xience alpine everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect of coronary stenting procedures.Additionally, the reported death appears to be related to the patient¿s overall condition and is considered unrelated to the xience pro a device.There is no indication of a product quality issue with respect to manufacture, design or labeling.The xience pro a device is currently not commercially available; however, it is similar to a device sold in the u.S.

Event Description

Notification was received from bfarm that indicated: the public prosecutor¿s office reported a procedure in 2019, that involved four xience proa stents, three were implanted without issue.The 4th 3.50x38mm had a reported deflation issue.During removal the device separated and the patient then died.An autopsy revealed a 32cm long catheter section with a balloon was found in the aorta up to the heart valves.A follow-up call to bfarm provided hospital name and advised dr.(b)(6) performed the procedure.The first notification to abbott was from bfarm on nov 9, 2020, which is why this event was not recorded in 2019.Further follow up with dr.(b)(6) confirmed the complaint was not reported to abbott during the time of the incident as she did not identify a device issue had occurred.She confirms that there was no deflation issue noted with the complaint device and no allegation against abbott.Per the physician¿s opinion, the patient died because of procedural circumstances and the state of the patient¿s overall condition.The patient had a history of st-elevation myocardial infraction (stemi) with coronary three-vessel disease, severe stenosis riva and proximal rcx and had previously suffered a myocardial infarction.Abbott was unable to perform an investigation of the device as it was never returned.Due to physician¿s statement, and the separated device being discarded, there is no indication that the event meets the definition of a reportable event per vorkommnis 29 of the mpg and is not reportable.

• Brand Name: XIENCE PROA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10943178
• MDR Text Key: 219494963
• Report Number: 2024168-2020-10166
• 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
• Type of Report: Initial
• Report Date: 12/03/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2022
• Device Catalogue Number: 1128350-38
• Device Lot Number: 9032161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2019
• 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
• Treatment: 2.75X15MM XIENCE PROA; 2.75X18MM XIENCE PROA; 3.0X33MM XIENCE PROA
• Patient Outcome(s): Required Intervention