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

Model Number 1550400-38

Device Problems Contamination /Decontamination Problem (2895); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a lesion located in the right coronary artery that was both heavily calcified and tortuous.While loading the xience sierra stent delivery system on the guide wire, the guide wire didn't come out the rapid exchange port.The physician kept pushing and it finally came out, but a small piece of plastic came out of where the wire came out.The delivery system was withdrawn and another xience sierra was used to complete the procedure with no delay or adverse patient effects.No additional information was provided.

Manufacturer Narrative

A visual, functional and dimensional inspection was performed on the returned device.The reported difficult to advance/position was confirmed.The reported contamination/decontamination problem could not be confirmed during return analysis testing as there was no contaminant present on the device.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 conclusive cause for the reported difficult to advance/position could not be determined.A conclusive cause for the reported contamination/decontamination problem could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• Brand Name: XIENCE SIERRA
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9468042
• MDR Text Key: 170793409
• Report Number: 2024168-2019-14518
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227547
• UDI-Public: 08717648227547
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2020
• Device Model Number: 1550400-38
• Device Catalogue Number: 1550400-38
• Device Lot Number: 902044A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR