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

Catalog Number 1550325-38

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Prolapse (2475)

Event Date 08/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.It should be noted that the reported patient effect of prolapse is listed in the xience sierra everolimus eluting coronary stent systems instructions for use (ifu) as known patient effect of coronary stenting procedures.The investigation determined the reported difficult to deploy (wall apposition) appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

Event Description

It was reported that this was a percutaneous intervention treating a mid left anterior descending (lad), severely calcified long lesion with heavy plaque burden.A 3.5x38mm xience sierra stent was implanted without issue when prolapsed material was observed through the implanted stent struts, resulting in poor wall apposition.There was no thrombus but rather plaque without any embolization noted.As treatment balloon angioplasty was performed and another stent was implanted.This resolved the issue and the patient remained in stable condition.No additional information was provided regarding this issue.

• 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# 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: 7846587
• MDR Text Key: 119237850
• Report Number: 2024168-2018-06882
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227387
• UDI-Public: 08717648227387
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2019
• Device Catalogue Number: 1550325-38
• Device Lot Number: 8032941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2018
• 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
• Patient Age: 56 YR
• Patient Weight: 153