FDA.reportPublic FDA data

MAUDE MDR 8707908

MDR report key
8707908
Report number
1820334-2019-01470
Event key
0
Event type
3
Date of event
2019-06-12
Date received
2019-06-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. LARRY POOL
Address
750 DANIELS WAY BLOOMINGTON IN 47404 US
Phone
812-812-8123
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FORMULA 418 RENAL BALLOON-EXPANDABLE STENTCOOK INCNING56610FOR418-18-80-5-209415254R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-06-1801. O; 2. R

Event Narratives#

N

Patient 1

COMMON NAME & PRODUCT CODE = NIN, STENT, RENAL. OCCUPATION = LAB MANAGER. PMA/510(K) NUMBER = P100028. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

D

Patient 1

AS REPORTED, DURING A PROCEDURE TO TREAT RENAL ARTERY STENOSIS INVOLVING A MALE PATIENT OF UNKNOWN AGE, A FORMULA 418 RENAL BALLOON-EXPANDABLE STENT BALLOON RUPTURED, DISPLACING THE STENT. THE PHYSICIAN REPORTEDLY ADVANCED THE STENT INTO THE RENAL ARTERY AND BELIEVES THAT THE CATHETER OF THE BALLOON WAS CUT BY THE PATIENT'S CALCIUM. THE BALLOON AND STENT WERE ADVANCED INTO THE INTENDED LOCATION; HOWEVER, THE PUNCTURED BALLOON WOULD NOT INFLATE. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE ENTIRE DEVICE WHEN THE STENT BECAME DISLOCATED OFF THE DELIVERY CATHETER OUTSIDE OF THE PLANNED LOCATION. ATTEMPTS TO RETRIEVE THE STENT WITH A SNARE WERE UNSUCCESSFUL. THE PHYSICIAN WAS ABLE TO MOVE THE STENT TO A LOCATION THAT WOULD NOT CAUSE ANY ISSUES AND THE STENT REMAINS IN THE PATIENT'S LEG. THERE ARE NO PLANS TO RETRIEVE THE STENT. THERE HAVE BEEN NO REPORTED ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS EVENT.