MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENTERPRISE2 4MMX16MM; INTRACRANIAL NEUROVASCULAR STENT

Model Number ENF401612

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint# (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter phone (b)(6).The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.The company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Based on the photo provided, no apparent damage could be appreciated on the picture.Only a part of the device and the label was shown.The reported condition ¿stent-inability to recapture¿ could not be evaluated based on the picture.Further investigation will be performed if the device returns for analysis.

Event Description

As reported by the field, during a stent-assisted aneurysm embolization, a 4mmx16mm enterprise2 stent (encr401612, 11199561) couldn't return into the unspecified microcatheter before ¿deployed to the mark¿.When it¿s deployed half but within the recyclable range.So, the physician withdrew the stent and microcatheter outside of the patient together.Cerebral target position was lost.The procedure was completed by another stent.There was no patient harm reported.

Manufacturer Narrative

Product complaint #
=
> (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during a stent-assisted aneurysm embolization, a 4mmx16mm enterprise2 stent (encr401612, 11199561) couldn't return into the unspecified microcatheter before ¿deployed to the mark¿.When it¿s deployed half but within the recyclable range.So, the physician withdrew the stent and microcatheter outside of the patient together.The cerebral target position was lost.The procedure was completed by another stent.There was no patient harm reported.No additional information is available.One non-sterile unit enterprise2 4mmx16mm was received inside of a pouch.The received device was visually inspected, and it was found that the stent was detached from the device and not returned for an evaluation, the rest of the device was found in good normal conditions.Also, a microscopic inspection was performed, and some biological residues were observed on the introducer.The functional analysis could not be performed due to the stent was found deployed.It is necessary that the stent is still inside of the introducer tube to perform the functional analysis.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 11199561.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The complaint reported by the customer ¿stent - inability to recapture¿ could not be evaluated since it was noted that the stent was detached from the device, however, the biological residues observed on the introducer may have been contributed to the complaint reported by the customer, for this reason, we can confirm the customer complaint.The biological residues noted on the device may have been related with insufficient flushing during the procedure, however, this cannot be conclusively determined.The analysis suggests that the failure reported by the customer could not be related to the manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure and damages on the returned system.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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

Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.One non-sterile unit enterprise2 4mmx16mm was received inside of a pouch.The received device was visually inspected, and it was found that the stent was detached from the device and not returned for an evaluation, the rest of the device was found in good normal conditions.Also, a microscopic inspection was performed, and some biological residues were observed on the introducer.The functional analysis could not be performed due to the stent was found deployed.It is necessary that the stent is still inside of the introducer tube to perform the functional analysis.(b)(6) medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 11199561.The history records indicate this product was final inspection tested at (b)(6)medical and was determined to be acceptable.The complaint reported by the customer ¿stent - inability to recapture¿ could not be evaluated since it was noted that the stent was detached from the device, however the biological residues observed on the introducer may have been contributed to the complaint reported by the costumer, for this reason we can confirm the customer complaint.The biological residues noted on the device may have be related with an insufficient flushing during the procedure, however this cannot be conclusively determined.The analysis suggest that the failure reported by the customer could not be related to the manufacturing process.Procedural factors and handling process may contribute to the failure as reported.Based on the information available, it has been determined that no corrective and preventive action is necessary at this time.

• Brand Name: ENTERPRISE2 4MMX16MM
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 10514585
• MDR Text Key: 206955857
• Report Number: 1226348-2020-00459
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10886704075332
• UDI-Public: 10886704075332
• Combination Product (y/n): N
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2022
• Device Model Number: ENF401612
• Device Catalogue Number: ENCR401612
• Device Lot Number: 11199561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Date Manufacturer Received: 10/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED MICROCATHETER