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

Catalog Number ENCR401612

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Udi unavailable.¿ initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The company is seeking this information through the event investigation.This is one of two products involved with the complaint and the associated manufacturer report numbers are 1226348-2019-01010.

Event Description

As reported by a healthcare professional, during a stent assist coil embolization, a 4mmx16mm enterprise2 stent ( encr401612, 11163863) couldn¿t be returned to the introducer completely.After the stent arrived at the target position, the physician thought it needed to be adjusted, then he withdrew it.After the stent went back and passed the prowler select microcatheter (mc), he found it stuck in the introducer.Therefore, the user pulled back the microcatheter and stent together out of the patient.The physician did not use the mc and or the enterprise stent anymore.A competitor¿s products were used to complete the operation.There was no patient injury reported.The target position was lost due to the micro catheter pulled back outside of patient.

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.Compliant conclusion: as reported by a healthcare professional, during a stent assist coil embolization, a 4mmx16mm enterprise2 stent (b)(4) couldn¿t be returned to the introducer completely.After the stent arrived at the target position, the physician thought it needed to be adjusted, then he withdrew it.After the stent went back and passed the prowler select microcatheter (mc), he found it stuck in the introducer.Therefore, the user pulled back the microcatheter and stent together out of the patient.The physician did not use the mc and or the enterprise stent anymore.A competitor¿s products were used to complete the operation.There was no patient injury reported.The target position was lost due to the micro catheter pulled back outside of patient.No additional information is available.A non-sterile unit enterprise2 4mmx16mm was received inside of a pouch.The delivery wire was inspected, and it was found stuck inside the introducer in good normal conditions.The introducer was inspected, and it was observed that it is different in color (white) and length.The stent was inspected, and it was found partially stuck inside the introducer.A comparison was performed using an enterprise2 4mmx16mm introducer good known lab sample and the complaint introducer enterprise2 4mmx16mm.A noticeable difference in color and length was noticed.Additionally, the delivery wire cannot be seen through the complaint introducer action that can be done on the good known sample.The length of both introducers were also measured for the received enterprise2 4mmx16mm, the introducer length is 120 cm, and for the enterprise2 4mmx16mm lab sample the length is 49 cm.During a microscopic inspection it was observed that the stents of both devices are similar.Lake region investigation was unable to confirm that the product did not meet specification prior shipment.The investigation concluded that the product met specification at the time of shipment.The complaint of "stuck in the introducer" is confirmed.At this time, it appears that the use of an incorrect introducer is the most likely cause for the event reported.A review of the device history records of the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.During manufacturing and packaging of this product the operators are instructed to 100% visual inspect for any obvious defect prior to shipment.The history records indicate this 11163863-lot product was final inspection tested at lake region medical and was determined to be acceptable.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.The instructions for use (ifu) instructs to advance the delivery wire to transfer the stent from the introducer into the infusion catheter.Warns that the delivery wire should not be torqued to gain access into the aneurysm.Continue advancing the delivery wire into the infusion catheter until the distal edge of the delivery wire reference marker (150 cm from the delivery wire distal tip) enters the introducer.Loosen the rhv locking ring, remove the introducer, and set it aside.Note: fluoroscopy may be used up to this point at the physician¿s discretion.Warns to not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance a new one.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).Updated section on this report: d4.Unique identifier( udi):(b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• 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: 9256752
• MDR Text Key: 219204815
• Report Number: 1226348-2019-01009
• Device Sequence Number: 1
• Product Code: NJE
• 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: 10/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2022
• Device Catalogue Number: ENCR401612
• Device Lot Number: 11163863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Initial Date Manufacturer Received: 10/12/2019
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: 11/04/2019; 12/02/2019
• Supplement Dates FDA Received: 12/02/2019; 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKPROWLERSELECT