MAUDE Adverse Event Report: PRESIDIO 18 CERE 9MMX33CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number PC4180933-30

Device Problem Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of event unknown, but was in 2017.Information regarding patient age, gender, weight, race, ethnicity and medical history could not be obtained.(b)(4).It was reported that the device would be returned for analysis; however, the product has not yet been returned.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, a presidio coil ((b)(4)) coil stretched during the procedure.The physician removed the coil safely and used another same size coil to complete the procedure.

Manufacturer Narrative

Product complaint # (b)(4).Additional information was received on 2/5/2018: the posterior communicating artery aneurysm was saccular.The coil stretched during positioning of the coil into the aneurysm.There had been no resistance when the coil was advanced/repositioning or withdrawn.The coil and sl10 microcatheter were removed together and the procedure was continued with the same microcatheter and a new coil.A continuous flush had been maintained through the microcatheter and there was no movement with the microcatheter while the coil was deploying.A one to one relationship between the coil and delivery tube was verified with fluoro prior to repositioning the coil.No additional intervention was required and there was no flow restriction/reduction as a result of the coil stretching.There were no patient adverse events.The patient age, weight, gender and medical history could not be obtained.Complaint conclusion: as reported by a healthcare professional, during posterior communicating artery coil embolization, a presidio coil (pc418093330/ c41500) coil stretched during positioning of the coil into the aneurysm.There had been no resistance when the coil was advanced, repositioning or withdrawn.The coil and sl10 microcatheter were removed together and the procedure was continued with the same microcatheter and a new coil.A continuous flush had been maintained through the microcatheter and there was no movement with the microcatheter while the coil was deploying.A one to one relationship between the coil and delivery tube was verified with fluoro prior to repositioning the coil.No additional intervention was required and there was no flow restriction/reduction as a result of the coil stretching.There were no patient adverse events.The patient age, weight, gender and medical history could not be obtained.It was reported that the device would be returned for analysis; however, after multiple attempts to obtain the device, the device was not returned.The presidio 18 cere product was not returned for investigation.This investigation will be re-opened if the device is returned.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The coil stretching could not be confirmed without product return for analysis.The root cause of the event could not be determined; however, procedural factors, such as the coil becoming entangled with previously implanted coils or the aneurysm during repositioning may have contributed to the event.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

Manufacturer Narrative

The device was returned for analysis on 4/4/2018.Complaint conclusion updated with failure analysis.As reported by a healthcare professional, during posterior communicating artery coil embolization, a presidio coil (pc418093330/ c41500) coil stretched during positioning of the coil into the aneurysm.There had been no resistance when the coil was advanced, repositioning or withdrawn.The coil and sl10 microcatheter were removed together with the presidio, and the procedure was continued with the same microcatheter and a new coil.A continuous flush had been maintained through the microcatheter and there was no movement with the microcatheter while the coil was deploying.A one to one relationship between the coil and delivery tube was verified with fluoro prior to repositioning the coil.No additional intervention was required and there was no flow restriction/reduction as a result of the coil stretching.There were no patient adverse events.The patient age, weight, gender and medical history could not be obtained.The device was returned for analysis on 4/4/2018.The embolic coil was not attached and was not returned.The device was mostly unsheathed.The resheathing tool was broken.The device positioning unit (dpu) core wire was kinked approximately 68 cm from the proximal end.There were bends in the dpu core wire at the strain relief and approximately 11 cm, 30 cm, 69 cm, 75 cm, 130 cm, 170 cm, and 171 cm from the proximal end.The resistance heating (rh) coil had not heated.No part of the embolic coil was attached to the dpu.The detachment fiber was not visible at the distal end of the dpu.While the resheathing tool was broken, its v-notch was undamaged.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.The complaint that the embolic coil was stretched cannot be confirmed because the embolic coil was not returned.The evidence that the rh coil has not heated indicates that the embolic coil detached mechanically, through the application of excessive force.The kink and bends in the dpu core wire and the broken resheathing tool are also indicative of the application of excessive force.A stretched embolic coil is generally the result of the application of excessive retraction force while the embolic coil is prevented from retracting.The circumstances surrounding the reported event are unknown.Thus, the reason for the application of force cannot be determined.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: PRESIDIO 18 CERE 9MMX33CM
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• MDR Report Key: 7150250
• MDR Text Key: 96055049
• Report Number: 3008114965-2017-00516
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K002056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: PC4180933-30
• Device Catalogue Number: PC418093330
• Device Lot Number: C41500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Date Manufacturer Received: 12/05/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1