MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC TRUFILL DCS ORBIT MINI COMPLEX FILL; CNV DCS ORBIT (HCG)

Catalog Number 637HF0208

Device Problems Migration or Expulsion of Device (1395); Difficult To Position (1467); Premature Activation (1484); Material Separation (1562); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been returned for analysis; however, the analysis has not yet been completed.Review of dhr for lot 16035935 concluded that 3 rejected units (loose contamination inside pebex) may be related to the reported complaint; however, the dhr review confirmed that the rejected units were properly segregated and discarded.No other issues were noted that were considered potentially related to the reported complaint.Information regarding age, gender, and weight were not provided.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, during coil embolization of an anterior communicating artery aneurysm, the trufill coil (637hf0208/ 16035935) had positioning difficulty and detached in the stryker sl10 microcatheter while re-positioning, then it came out of the aneurysm and was in the anterior communicating artery.Due to the coil migration causing restriction in arterial blood flow, they placed an enterprise vrd to push the coil to the arterial wall.When the coil detached, it was partly in the microcatheter and partly in the aneurysm.There had been no resistance between the coil and microcatheter, and a continuous flush had been maintained through the microcatheter.It was reported that the microcatheter had not been repositioned over the coil while the coil was deployed or partially deployed out of the distal end of the microcatheter.Other coils had been placed in the aneurysm prior to this incident; however, coil entanglement was not suspected to contribute to the coil detachment.It was reported that the patient was doing okay after the procedure, and there was no adverse outcome to the patient as a result of the event.It was further reported that the event did not result in a clinically significant delay in the procedure.This was the last coil to be implanted, and no further intervention was planned; however, they would continue to follow the patient.

Manufacturer Narrative

Complaint conclusion: as reported by a healthcare professional, during coil embolization of an anterior communicating artery aneurysm, the trufill coil (637hf0208/ 16035935) had positioning difficulty and separated in the stryker sl10 microcatheter while re-positioning, then it came out of the aneurysm and was in the anterior communicating artery.Due to the coil migration causing restriction in arterial blood flow, they placed an enterprise vrd to push the coil to the arterial wall.When the coil detached, it was partly in the microcatheter and partly in the aneurysm.There had been no resistance between the coil and microcatheter, and a continuous flush had been maintained through the microcatheter.It was reported that the microcatheter had not been repositioned over the coil while the coil was deployed or partially deployed out of the distal end of the microcatheter.Other coils had been placed in the aneurysm prior to this incident; however, coil entanglement was not suspected to contribute to the coil detachment.It was reported that the patient was doing okay after the procedure, and there was no adverse outcome to the patient as a result of the event.It was further reported that the event did not result in a clinically significant delay in the procedure.This was the last coil to be implanted, and no further intervention was planned; however, they would continue to follow the patient.A non-sterile orbit helical fill 2x8 was received coiled in the dispenser in a plastic bag.No damages were noted on the hub.The hypotube was inspected and it was found kinked.The introducer was received zipped and it was found without damage.The support coil, gripper and headpiece were received inside of the introducer.The support coil was found without any damage.The gripper was inspected and it was found in elongation condition and the headpiece attached in the gripper while the rest of the embolic coil was not return for evaluation.The gripper and headpiece were inspected under microscope; elongation condition was found on gripper.The soldered section between the headpiece and the coil loops was not fractured so this means that the solder had a good adhesion to the headpiece.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.The coil migration, protrusion into the parent vessel, and positioning difficulty could not be evaluated due to the nature of the event ad no procedural films to review.The detachment in the microcatheter was not confirmed since the headpiece was still attached to the gripper; however, it was confirmed that the coil had separated.Coil migration is a known procedure complication during coil embolization procedures and is listed in the instructions for use as such.The failure experienced by the customer and the damages found on the device could not be conclusively determined; however procedural factors may have contributed to the coil separation.The elongation of the coil headpiece suggests that the device was stretched prior to separating.As listed in the instructions for use: ¿during coil retraction, verify under fluoroscopy that a one-to-one relationship exists between the delivery tube and the coil.If not, the coil has been stretched, which could lead to premature detachment or coil fracture.If the one-to-one relationship does not exist, remove the infusion catheter and the detachable coil as an assembly and replace.¿ inspections are in place to prevent this type of damage from leaving the manufacturing facility.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process; therefore, no corrective actions will be taken at this time.Additional information received through failure analysis on 11/11/2015 revealed that the coil did not prematurely detach.It had separated.(b)(4).

• Brand Name: TRUFILL DCS ORBIT MINI COMPLEX FILL
• Type of Device: CNV DCS ORBIT (HCG)
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: kimberly soter ; 14700 nw 57th court; miami lakes, FL 33014 ; 5088288310
• MDR Report Key: 5191173
• MDR Text Key: 29935002
• Report Number: 1058196-2015-00193
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K053197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: 637HF0208
• Device Lot Number: 16035935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention