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

Catalog Number	FOR418-18-135-6-16
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E3: occupation = vascular/cardiac/thoracic surgeon.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 placement of a stent within the celiac artery, a formula 418 renal balloon-expandable stent slipped off the delivery balloon.Access was obtained in the right common femoral artery.Upon advancement of the device into the patient, it would not advance into the celiac artery over the wire guide.The user did not use the insertion tool or a tuohy-borst adapter for insertion of the stent into the sheath.The anatomy was both tortuous and calcified.The physician removed the stent delivery system in order to try a different catheter; however, when the delivery system was removed from the "diaphragm" of the sheath, the stent slid off the balloon.The physician was reportedly not aware that the stent had slipped off the balloon, and the sheath was flushed, pushing the stent out of the sheath and into the aorta and subsequently to the hypogastric/internal iliac artery.Because it would have caused more harm to the patient to remove the stent, the stent was intentionally left in the hypogastric/internal iliac artery.Another device of the same type was used to complete the procedure without further complication.The patient is reportedly doing well.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
Additional information, received 31aug2023, was inadvertently omitted from the initial report.The insertion tool was used during insertion of the stent system into the sheath.Resistance was not encountered upon advancement/manipulation of the stent catheter system through the sheath.The stent slipped off the balloon delivery system as it was removed through the sheath hub.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional/corrected information: b5 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
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during a procedure involving placement of a stent within the celiac artery, a formula 418 renal balloon-expandable stent slipped off the delivery balloon.Access was obtained in the right common femoral artery.Upon advancement of the device into the patient, it would not advance into the celiac artery over the wire guide.The anatomy was both tortuous and calcified.The insertion tool was used during insertion of the stent system into the sheath.Resistance was not encountered upon advancement/manipulation of the stent catheter system through the sheath.The physician removed the stent delivery system in order to try a different catheter; however, when the delivery system was removed from the "diaphragm"/hub of the sheath, the stent slid off the balloon.The physician was reportedly not aware that the stent had slipped off the balloon, and the sheath was flushed, pushing the stent out of the sheath and into the aorta and subsequently to the hypogastric/internal iliac artery.Because it would have caused more harm to the patient to remove the stent, the stent was intentionally left in the hypogastric/internal iliac artery.Another device of the same type was used to complete the procedure without further complication.The patient is reportedly doing well.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.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 lot.A review of complaint history found no additional complaints for this lot number.The product ifu states ¿do not attempt to pull an unexpanded stent back into the guiding catheter/introducer¿ withdraw the guiding catheter/introducer and stent delivery system as a single unit, leaving the wire guide in place.¿ the information provided upon review of the complaint file, device master record (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.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that failure to follow instructions contributed to this event.The user reported that the stent was being pulled back through the sheath during the procedure.The ifu states ¿do not attempt to pull an unexpanded stent back into the guiding catheter/introducer¿ withdraw the guiding catheter/introducer and stent delivery system as a single unit, leaving the wire guide in place.¿ it is likely that the stent dislodged because the delivery catheter and sheath were not removed as a unit.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 17686249
• Report Number: 1820334-2023-01152
• Device Sequence Number: 15047514
• Product Code: NIN
• UDI-Device Identifier: 10827002566269
• UDI-Public: (01)10827002566269(17)250301(10)14567776
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2025
• Device Catalogue Number: FOR418-18-135-6-16
• Device Lot Number: 14567776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2023
• Supplement Date Received by Manufacturer: 08/31/2023; 11/30/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 09/15/2023; 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• 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: COOK 300CM EXTRA SUPPORT ROADRUNNER WIRE; COOK 6FR 55 HIGH-FLEX ANSEL SHEATH
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR
• Patient Sex: Female