FORMULA 418 RENAL BALLOON-EXPANDABLE STENT

Report

Report Number: 1820334-2024-01403
Event Type: Malfunction
Date Received: October 25, 2024
Date of Event: October 9, 2024
Report Date: April 23, 2025
Manufacturer: COOK INC
Product Code: NIN
UDI-DI: 10827002566092
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: NURSE
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

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.

Additional Manufacturer Narrative · 0

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.

Description of Event or Problem · 0

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1001250	FORMULA 418 RENAL BALLOON-EXPANDABLE STENT	NIN STENT, RENAL	NIN	COOK INC	G56609	15768326	10827002566092

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Female		MACH7 6-FRENCH GUIDE.\| STERLING BALLOON 3X30.