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

Catalog Number 1500350-18

Device Problems Device Markings/Labelling Problem (2911); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anaphylactic Shock (1703); Bradycardia (1751); Cardiac Arrest (1762); Death (1802); Hypersensitivity/Allergic reaction (1907)

Event Date 03/31/2019

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.The other xience sierra stent system and the trek balloon referenced are filed under separate medwatch reports.

Event Description

It was reported that this was a routine percutaneous coronary intervention (pci) procedure in a stable patient who presented with a non-st-elevation myocardial infarction.The patient had a history of previous anaphylaxis to peg-7 (polyethylene glycol).Within minutes of introducing the trek rx balloon dilation catheter, the patient developed bradycardia and hypotensive shock.Two xience sierra stents were rapidly placed in the left anterior descending coronary artery.At some point during the procedure, the patient went into pulseless electrical activity (pea).Resuscitation was unsuccessful, and patient expired.No additional information was provided.

Manufacturer Narrative

(b)(4).There was no reported device malfunction and the product was not returned as the stent remains implanted.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of cardiac arrest, death, and hypersensitivity are listed in the sierra everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects of bradycardia, cardiac arrest, death, hypersensitivity, and the relationship to the product, if any, cannot be determined.The investigation determined the reported shock appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

Manufacturer Narrative

(b)(4).

Event Description

Subsequent to the follow-up #1 medwatch report, the allergy was clarified as polyethylene glycol (peg).

• Brand Name: XIENCE SIERRA 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# 3005718570; 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: 8668889
• MDR Text Key: 147014371
• Report Number: 2024168-2019-04409
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup,Followup
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2021
• Device Catalogue Number: 1500350-18
• Device Lot Number: 8110841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• 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): Death