MAUDE Adverse Event Report: MEDTRONIC MEXICO CONCERTO NYLON; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number NV-5-15-HELIX

Device Problems Break (1069); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/03/2024

Event Type  Injury  

Event Description

Medtronic received a report that the concerto coil prematurely detached in the catheter.During fluoroscopy, unknown foreign material was found in the patient and the physician left the material remaining in the patient.The patient was undergoing surgery to close vessels supplying blood flow to an endoleak.It was noted the patient's vessel tortuosity was severe.It was reported that upon initially deploying the concerto coil, the physician partially deployed the coil, but realized he would like a shorter length coil.Upon retrieval of the coil, the coil prematurely deployed partially inside the microcatheter.The pusher wire was retrieved and a separate wire was used to try and push the remaining coil out of the microcatheter.There was resistance in pushing the wire into the catheter somewhere in the microcatheter.Eventually a 1cc syringe was injected into the catheter to push the remaining part of the coil out of the microcatheter which was successful.The wire was then successfully re-introduced into the microcatheter and the microcatheter repositioned 2 additional 4x8mm concerto coils, which were successfully delivered and deployed.It was only after the successful completion of the case and when flushing the sheath after removing the microcatheter that a small very thin looking ribbon of material was noticed hanging out of the sheath.The physician attempted to retrieve the material but it broke in his hand.Upon flouro examination in cine-burst, it was noted a very thin radiopaque material was still in the patient in the track to the area of where the coil was deployed.It was unknown what the product was, but the physician did leave the material in the patient as is.It was reported coil separation/break/premature detachment occurred.The coil remained in the patient.There was no surgical or medicinal intervention required.The pushwire was not bent or broken.There was no friction or difficulty during delivery.The physician attempted to reposition the coil.He only attempted to take out the coil from the patient once to replace for a different size.The physician did not attempt to detach the coil.The physician did not rotate the delivery pusher during the procedure.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.Ancillary devices include a renegade straight microcatheter m001182530.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received that no attempts to detach were made, they were simply trying to remove the coil to replace it with another size.The pushwire was not damaged.It only got kinked after it was removed on the field while coiling it to save for the rep.The coil uncoiled and was left in the patient.This was the first coil implanted.Two 4x8 coils were successfully implanted after this coil.It was decided that surgery was not needed.

Manufacturer Narrative

Product analysis of nv-5-15-helix, lotno:227307377 found the actuator interface securely attached to the coupler tube.No evidence of detachment using an instant detacher was found at this location.The break indicator was found with two breaks.All three segments were retained by the release wire.This is typically an indication of manual detachment attempts.The concerto pusher was bent at ~14.0cm from the proximal end; and bent at ~10.4cm form the distal end.The coin was found fully retracted out of the lumen stop.The shield coil was found stretched.The implant coil was already detached and not returned for analysis.Customer reported the implant remained within the patient.The retainer ring was found damaged.The coin was found undamaged.The inner diameter of the retainer ring could not be reliably measured due to the damaged condition.The coin was measured at three locations to be ~0.076mm @ 0.063mm, ~0.092mm @ 0.127mm, and ~0.095mm@ 0.275mm, which is within specifications (specification: 0.063mm ¿ 0.089mm @ 0.063mm, 0.075mm ¿ 0.105mm @ 0.127mm, 0.086mm ¿ 0.108mm @ 0.275mm).Based on the device analysis and reported information, the customer report of ¿p remature detachment¿ was confirmed.The break indicator was found broken twice and the coin/release wire were fully retracted out of the lumen stop.This would detach the implant coil as designed by the detachment subassemblies.However, customer reported no breaks or kinks to the pusher, and that the ¿kinked¿ did not occur until after the procedure when the device was coiled to send for analysis.Therefore, pusher break could not be confirmed to have occurred during the procedure.The retainer ring was found damaged, potentially contributing towards the reported premature detachment.In addition, the shield coil was found stretched and the pusher was found bent.These are usually indicative of advancing/retracting against high resistance or tortuous anatomy.As the implant coil and renegade micro catheter used during the event was not returned for analysis, any contribution of the implant coil and micro catheter towards the premature detachment could not be determined.Customer reported pushing the implant into the patient after it detached within the micro catheter, which is off label use.The renegade has an inner diameter of 0.021¿ (per boston scientific website) and is therefore compatible for use with the concerto coil.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CONCERTO NYLON
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 18566804
• MDR Text Key: 333516510
• Report Number: 9612164-2024-00376
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536044937
• UDI-Public: 00847536044937
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NV-5-15-HELIX
• Device Catalogue Number: NV-5-15-HELIX
• Device Lot Number: 227307377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other