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

Model Number G56611

Device Problem Premature Separation (4045)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); No Consequences Or Impact To Patient (2199)

Event Date 02/05/2020

Event Type  Injury  

Manufacturer Narrative

Common name & product code: nin, stent, renal.Occupation: unknown.Pma/510(k) number: p100028.Device evaluated by mfg: device evaluation has begun; however, a conclusion is not yet available.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during placement of a stent within the renal artery, two formula 418 renal balloon-expandable stents came off the delivery systems.The procedure was ultimately aborted due to hemodynamic changes in the patient.There has been no report that this event caused or contributed to the hemodynamic changes.Per the initial reporter, a section of the device did not remain inside the patient¿s body.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.Additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.

Event Description

Additional information was received 16apr2020.The two-month-old patient's blood pressure was reportedly 70/40.Access was obtained in the femoral vein.During attempts to place the stent, the patient's blood pressure and heart rate declined and pacing was required to maintain the patient's blood pressure.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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.

Manufacturer Narrative

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 Description

Additional information received 25feb2020.As reported, the stent became stuck within the hemostatic valve of a previously inserted sheath, causing the stent to fall off the balloon.The stent did not fall off in the patient.The event prolonged the time that the sheath was in place across the patient's tricuspid valve, contributing to tricuspid regurgitation and hypotension, but the patient did not require any interventions or experience any adverse effects due to these.

Manufacturer Narrative

Event summary: as reported, two formula 418 renal balloon-expandable stents became stuck within the hemostatic valve of a previously inserted sheath, causing the stents to fall off the balloon.The devices were used to attempt to stent a right-ventricle-to-pulmonary-artery conduit previously created in a norwood operation due to a history of hypoplastic left heart syndrome.The stents did not fall off in the patient.The event prolonged the time that the sheath was in place across the patient's tricuspid valve, contributing to tricuspid regurgitation and hypotension.During attempts to place the stents, the patient's blood pressure and heart rate declined and pacing was required to maintain the patient's blood pressure.Investigation - evaluation: reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, and quality control procedures and a visual inspection and dimensional verification of the device were conducted during the investigation.Two used for418-18-80-6-12 stents were returned for investigation, along with one insertion tool.The first device¿s stent was found on the shaft having slid off towards the hub 33 cm from strain relief.Both marker bands were present on the device.There were pillowing/indentations of the balloon, suggesting that the stent was heat set and seated in place during the manufacturing of the device.The crimped stent length of the stent in its current state measured within specification.The second device was returned without a stent present.Both marker bands were present on the device.There were pillowing/indentations of the balloon, suggesting the stent was heat set and seated in place during manufacturing.A document-based investigation evaluation was performed.A review of the device history record showed no failure-related nonconformances.Two additional complaints comprising three total devices from this product lot were also received, each describing the similar failure of the stent coming off of the balloon.No gaps were discovered in the manufacturing instructions, drawing, or quality control procedures for this device.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is packaged with instructions for use, which state, ¿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.¿ based on the information available, investigation has concluded that a cause for this event could not be established.A capa has been initiated to further investigate this failure mode.A recall-removal was executed for product lot 10153876.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.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 Description

Additional information received 11jun2020.The devices were used to attempt to stent a right-ventricle-to-pulmonary-artery conduit previously created in a norwood operation due to a history of hypoplastic left heart syndrome.

• Brand Name: FORMULA 418 RENAL BALLOON-EXPANDABLE STENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9732368
• MDR Text Key: 184138720
• Report Number: 1820334-2020-00406
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 10827002566115
• UDI-Public: (01)10827002566115(17)221115(10)10153876
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/06/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2022
• Device Model Number: G56611
• Device Catalogue Number: FOR418-18-80-6-12
• Device Lot Number: 10153876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 02/20/2020
• Supplement Dates Manufacturer Received: 02/25/2020; 04/16/2020; 06/16/2020
• Supplement Dates FDA Received: 03/05/2020; 04/27/2020; 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1820334-10APR2020-002-R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 MO