MAUDE Adverse Event Report: COOK INC FORMULA 418 RENAL BALLOON-EXPANDABLE STENT; NIN STENT, RENAL

Model Number	G56609
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: pma/510(k) number = p100028.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
As reported, during a procedure involving implantation of a stent within the renal artery, a formula 418 renal balloon-expandable stent slipped off the balloon.The device was loaded through another manufacturer¿s 6-french guide and advanced near the renal artery.The insertion tool was not used to insert the device into the guide/sheath; however, a large tuohy-borst adapter was used during insertion.The stent was not moistened with heparinized saline and gauze was not used to moisten the stent.The reference vessel diameter was approximately six millimeters, and the lesion was less than five centimeters long.The anatomy was tortuous, and the lesion was calcified and ninety percent stenosed.As the user attempted to maneuver the stent through the stenosed lesion, the stent slipped off the balloon.The physician was able to quickly capture and retrieve the stent using another manufacturer¿s balloon, and the stent was then deployed and implanted in the renal artery as intended.The patient did not require any additional procedures or experience any adverse effects due to this event.
Additional Manufacturer Narrative
Summary of event: as reported, during a procedure involving implantation of a stent within the renal artery, a formula 418 renal balloon-expandable stent slipped off the balloon.The device was loaded through another manufacturer¿s 6-french guide and advanced near the renal artery.The insertion tool was not used to insert the device into the guide/sheath; however, a large tuohy-borst adapter was used during insertion.The stent was not moistened with heparinized saline and gauze was not used to moisten the stent.The reference vessel diameter was approximately six millimeters, and the lesion was less than five centimeters long.The anatomy was tortuous, and the lesion was calcified and ninety percent stenosed.As the user attempted to maneuver the stent through the stenosed lesion, the stent slipped off the balloon.The physician was able to quickly capture and retrieve the stent using another manufacturer¿s balloon, and the stent was then deployed and implanted in the renal artery as intended.The patient did not require any additional procedures or experience any adverse effects due to this event.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the final or sub-assembly lots.A review of complaint history found no additional complaints for this lot number.The product ifu states ¿special care must be taken not to handle or in any way disrupt the stent on the balloon.This is particularly important during removal of the catheter from packaging, placement over the wire guide, and advancement through the large-bore tuohy borst ¿y¿ adapter and guiding catheter hub.¿ a review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, and ifu suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that the patient¿s anatomy contributed to this event.Because the stent was advanced through tortuous anatomy and the stent slipped from the balloon during attempted advancement through the calcified and ninety percent stenosed target lesion, it is possible/likely that the stent was disrupted during advancement and subsequently slid from the balloon.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified, and cook will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: FORMULA 418 RENAL BALLOON-EXPANDABLE STENT
• Common Device Name: NIN STENT, RENAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 20537816
• Report Number: 1820334-2024-01403
• Device Sequence Number: 15336381
• Product Code: NIN
• UDI-Device Identifier: 10827002566092
• UDI-Public: (01)10827002566092(17)261122(10)15768326
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G56609
• Device Catalogue Number: FOR418-18-80-5-16
• Device Lot Number: 15768326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MACH7 6-FRENCH GUIDE.; STERLING BALLOON 3X30.
• Patient Sex: Female
• Patient Weight: 57 KG