MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM; CNV ENTERPRISE SES (NJE)

Catalog Number ENC453712

Device Problems Device Expiration Issue (1216); Difficult to Remove (1528); Physical Resistance (2578); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2015

Event Type  malfunction  

Manufacturer Narrative

The device has been returned for analysis; however, the analysis has not yet been completed.This is 1 of 2 mdr reports being submitted for this complaint, with associated report numbers of 1058196-2016-00013 and 1058196-2016-00012.Additional information will be submitted within 30 days of receipt.

Event Description

It was reported that during embolization of an intracranial aneurysm with use of an enterprise stent (enc453712/ 10191779), the physician was ¿unable to successfully push ahead when connected prowler, also cannot be recycled, and this issue is resulting to release half.¿ in addition, the device was used beyond the use by date.The expiration date was 09/30/2014 and the device was used on (b)(6) 2016.It was reported that the outcome of the procedure was unknown; however, there were no potential patient adverse events and no delay in the procedure.The device had been stored as per the labeling instructions.It was reported that the device would be returned for analysis.Additional event clarification has been requested.

Manufacturer Narrative

Correction: this report is a 30 day report instead of a 10 day report as previously reported.

Manufacturer Narrative

Additional information was received in 02/04/2016.The aneurysm was in the middle cerebral artery.The physician had positioned the stent for deployment by aligning the stent positioning marker of the delivery wire with the target site, and the enterprise had not been advanced further than the point of the prowler select plus (catalog 606s255x/lot unk) microcatheter distal markerband as per the instructions for use (ifu).The stent was partially deployed and could not be recaptured.When attempting to remove the enterprise from the prowler, there was resistance between the enterprise and prowler, and the enterprise became stuck in the prowler.The enterprise and prowler were both removed from the patient.It was reported that a flush had been maintained through the prowler.Neither the prowler nor the enterprise appeared damaged, and the procedure was completed with another microcatheter and enterprise.It was reported that the devices had been prepped and used as per the ifu.It was confirmed that the device had not been used beyond expiration date.The correct event date was (b)(6) 2014.The patient was a (b)(6) female with a history of hypertension and intracranial aneurysm.Conclusion: as reported by a healthcare professional, during embolization of a middle cerebral artery aneurysm with use of an enterprise stent (enc453712/10191779), there was resistance between the enterprise and the prowler select plus (606s255x/lot unk) after the stent was partially deployed, and the stent could not be re-captured.The stent and microcatheter had to be removed as a unit.The devices had been prepped and used as per the instructions for use (ifu).A flush had been maintained through the microcatheter.Neither the prowler select plus nor the enterprise appeared damaged, and the procedure was completed with another microcatheter and stent.There were no potential adverse events, and no delay in the procedure.The devices had been stored as per labeling instructions.A non-sterile enterprise device was received inside of a plastic bag.The device was inspected, and no damages were noted.No obvious damages were noted on the delivery wire, and the stent was in its original position.In the same plastic bag, a non-sterile prowler select plus was received, it was inspected and no damages were noted.The stent was inspected under microscope, and no damages were noted.The functional analysis was performed, and no complications were noted during the functional test.The received microcatheter was flushed using a lab sample syringe.The received enterprise device was introduced into the microcatheter, and it can be advance through the device until the distal end without any difficulty.Lake region medical reviewed the device history records relative to the manufacturing, inspecting and packaging of the lot 10191779.The device history record review also included a review of the certificate of conformance received from specialty coatings systems and nitinol devices and components, along with lake region medical¿s internal receiving inspection records for the stents issued to the complaint lot.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The resistance, partial deployment and re-capture difficulty could not be confirmed during the functional analysis.Neither the product analysis nor the dhr for the enterprise or the prowler select plus suggests that the failure could be related to the manufacturing process.Procedural factors and handling process may have contributed to the failure reported.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective action will be taken at this time.This is 1 of 2 mdr reports being submitted for this complaint, with associated report numbers of 1058196-2016-00013 and 1058196-2016-00012.

• Brand Name: ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
• Type of Device: CNV ENTERPRISE SES (NJE)
• 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: 5398602
• MDR Text Key: 37106261
• Report Number: 1058196-2016-00012
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: H60001
• 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,Followup
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Catalogue Number: ENC453712
• Device Lot Number: 10191779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1