FDA Adverse Event Malfunction Summary report: N

EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED

MDR report key: 9443471 · Received December 10, 2019

Report

Report Number: 3001845648-2019-00699
Event Type: Malfunction
Date Received: December 10, 2019
Date of Event: November 4, 2019
Report Date: December 10, 2019
Manufacturer: COOK IRELAND LTD
Product Code: MUM
UDI-DI: 10827002480251
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

510(K)#: K163468. LAB EVALUATION COMPLETED ON 05-DEC-2019 THAT CONFIRMED THE FLEXOR DID NOT KINK/BREAK. THIS FILE WAS INITIALLY ASSESSED AS "FLEXOR KINKED/BROKEN" WHICH IS A MALFUNCTION PRECEDENCE. THIS FILE HAS BEEN RE-ASSESSED BASED ON THE LAB EVALUATION DETAILS AND NO LONGER MEETS THE FDA MDR REPORTING CRITERIA OF A MALFUNCTION REPORT.

Description of Event or Problem · 0

THIS REPORT IS BEING SUBMITTED TO CANCEL THE INITIAL REPORT SUBMITTED BASED ON THE RECEIPT OF ADDITIONAL INFORMATION.

Additional Manufacturer Narrative · 1

510(K)#: K163468 INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

Description of Event or Problem · 1

THE STENT WAS PUT DOWN INTO THE PATIENT, BUT WOULD NOT DEPLOY. PROCEDURE WAS COMPLETED USING ANOTHER STENT. "AS PER COMPLAINT FORM"; STAFF ADVISED THE STENT WAS IN POSITION OVER THE GUIDEWIRE AND WHEN THEY REMOVED THE RED INDICATOR TAB TO SQUEEZE THE TRIGGER THE STENT FAILED TO DEPLY AT ALL. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1238752	EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED	MUM STENT, METALIC EXPANDABLE, DUODENAL	MUM	COOK IRELAND LTD	G48025	C1571377	10827002480251

Patients

Seq	Age	Sex	Outcome	Treatment
1