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

Model Number G56611

Device Problem Premature Separation (4045)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

Common name & product code = nin; stent, renal.Initial reporter occupation = supply chain specialist.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.

Event Description

As reported, prior to patient contact, a formula 418 renal balloon-expandable stent fell off the balloon as the stent delivery system was advanced directly over a wire guide.Access was obtained in the right femoral vein with a long 5 french flexor sheath.The insertion tool was not used, nor was a tuohy-borst "y" adapter.The complaint device was intended to be used in a stenosed left pulmonary artery.Another device of the same type and size was used to complete the procedure without complication.

Manufacturer Narrative

Description of event: as reported, prior to patient contact, a formula 418 renal balloon-expandable stent fell off the balloon as the stent delivery system was advanced directly over a wire guide.Access was obtained in the right femoral vein with a long 5 french flexor sheath.The insertion tool was not used, nor was a tuohy-borst "y" adapter.The complaint device was intended to be used in a stenosed left pulmonary artery.Another device of the same type and size was used to complete the procedure without complication.Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, documentation, drawings, the instructions for use, manufacturing instructions, and quality control data.One for 418 balloon stent catheter was returned to cook for investigation.Inspection found the stent had slid off the balloon and was on the catheter shaft.Additional photos of the device were taken using the scope.Inspection of the balloon found indentations in the balloon material suggesting that the stent was heat set and crimped in place during the manufacturing of the device.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: device description: ¿the formula renal stent is a balloon-expandable stent made of 316l stainless steel with a slotted tube configuration.It is pre-mounted on an over-the-wire balloon catheter, which serves as the delivery system (formula 418 renal balloon-expandable stent system).The stent is positioned between two radiopaque marker bands, which are located inside the balloon at the proximal distal tapers of the balloon.The cannula design of the stent provides a low outside diameter profile, which permits use with a 5.0 french sheath and a 6.0 french guiding catheter for 4-6mm diameter sizes; and a 6.0 french sheath and 7.0 french guiding catheter for the 7.0mm diameter size.The formula rental stent is premounted on 80 and 135 cm balloon catheter delivery systems.The stent is available in nominal expanded diameters of 4, 5, 6 and 7mm with lengths of 12, 16, and 20 mm each.¿ intended use: ¿the formula 418 renal balloon-expandable stent system is indicated for use in patients with atherosclerotic disease of the renal arteries following suboptimal percutaneous renal angioplasty (ptra) of a de novo or restenotic lesion (= 18 mm in length) located within 10 mm of the renal ostium and with a reference vessel diameter of 4.0 ¿ 7.0 mm.Suboptimal ptra is defined as = 50% residual stenosis, = 20mmhg systolic or = 10 mmhg mean translesional pressure gradient, or flow-limiting dissection.¿ precautions: ¿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 through the large-bore tuohy-borst ¿y¿ adapter and guiding catheter hub.¿ stent placement: ¿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.¿ product recommendations: wire guide use and selection.¿the formula 418 renal balloon-expandable stent system is compatible with 0.018 inch wire guides.¿ guiding catheter/introducer selection: ¿correct guiding catheter / introducer selection and technique are necessary for use of the stent.Ensure that the inside lumen of the guiding catheter / introducer is of sufficient size to allow unobstructed passage of the formula 418 renal balloon-expandable stent system.¿ preparation of balloon catheter: ¿remove the formula 418 renal balloon-expandable stent system from the package, remove protective sleeve from the distal tip of the catheter, and inspect the stent to ensure it has not been damaged.¿ ¿before inserting the formula 418 renal balloon-expandable stent system into the guiding catheter or introducer, be sure that a large-bore tuohy-borst ¿y¿ adapter or introducer valve is on the guiding catheter / introducer.¿ ¿insert the appropriate guiding catheter/introducer.¿ ¿advance the premounted formula 418 renal balloon-expandable stent system over the wire into either the introducer valve or tuohy borst ¿y¿ adapter.¿ ¿if using an introducer with a valve, make sure the flared end of the insertion tool (provided in the package) is loaded over the premounted stent on the balloon catheter.Pass the insertion tool loaded with the premounted stent through the introducer valve.Push the formula 418 renal balloon-expandable stent system into the body of the introducer.Slide the insertion tool proximally up the catheter shaft away from the guiding catheter/introducer.A slight contact of the stent with t introducer may be felt, but there must be no resistance.¿ ¿if using a tuohy-borst ¿y¿ adapter, advance the premounted formula 418 renal balloon-expandable stent system over the wire and into the fully opened large-bore tuohy-borst ¿y¿ adapter.Gently advance the formula 418 renal balloon-expandable stent system completely thought the tuouhy-borst ¿y¿ adapter and into the guiding catheter/ introducer.A slight contact of the stent with the guiding catheter/introducer may be felt, but there must be no resistance.¿ ¿warning: if resistance is encountered, do not force passage.Resistance may indicate damage to stent.¿ removal of unexpanded stent: ¿do not attempt to pull an unexpanded stent back into the guiding catheter / introducer.The formula 418 renal balloon-expandable stent system should be withdrawn until the proximal end of the stent is aligned with the distal tip of the guiding catheter / introducer.Withdraw the guiding catheter / introducer and stent delivery system as a single unit, leaving the wire guide in place.Warning: if stent is removed, do not attempt to reuse the device.Damage to the stent may occur upon removal.¿ how supplied: ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ a capa has been previously opened for the failure mode of formula 418 stent detachment/slippage from balloon delivery system.The capa is currently in progress.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded a definitive conclusion could not be determined.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No new patient or event information to report.

• Brand Name: FORMULA 418 RENAL BALLOON-EXPANDABLE STENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10710433
• MDR Text Key: 213901387
• Report Number: 1820334-2020-01910
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 10827002566115
• UDI-Public: (01)10827002566115(17)230330(10)13094041
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2023
• Device Model Number: G56611
• Device Catalogue Number: FOR418-18-80-6-12
• Device Lot Number: 13094041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Date Manufacturer Received: 01/18/2021
• Patient Sequence Number: 1