MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC EU ENT4.5MMD 22MML WNO DSTL TP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452200

Device Problems Difficult or Delayed Positioning (1157); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

As reported by a healthcare professional, during a stent-assisted aneurysm embolization, the stent of a 4.5 mmd 22 mml enterprise (enc452200, 11151397) could not deploy when the physician pulled back the catheter a lot.The physician tried about three times, the stent couldn¿t deploy at all.The user withdrew the stent and catheter out of the patient together.The target position was lost.A new stent and microcatheter of the same product code was used to complete the procedure.The stent was pulled and pushed not smoothly in the micro catheter.No patient injury was reported.The target vessel was ¿normal¿.Additional information indicated that the device was inspected for damage prior to use.The event did not result in additional intervention.Adequate flush was maintained through the devices.There was no prolongation of the procedure due to the event.The concomitant devices functioned as expected.

Manufacturer Narrative

Product complaint (b)(4).The enterprise stent was received with a prowler select microcatheter connected to it, therefore, the section of concomitant products has been updated.Section h3: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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 1226348-2019-00993.

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 a healthcare professional, during a stent-assisted aneurysm embolization, the stent of a 4.5mmd 22mml enterprise (enc452200, 11151397) could not deploy when physician pulled back the catheter a lot.The physician tried about three times, the stent couldn¿t deploy at all.The user withdrew the stent and catheter out of patient together.The target position was lost.A new stent and microcatheter of the same product code was used to complete the procedure.The stent was pulled and pushed not smoothly in the micro catheter.No patient injury was reported.The target vessel was ¿normal¿.Additional information indicated that the device was inspected for damage prior to use.The event did not result in additional intervention.The adequate flush was maintained through the devices.There was no prolongation of the procedure due to the event.The concomitant devices functioned as expected.A non-sterile eu ent4.5mmd 22mml wno dstl tp was received inside of a pouch.The eu ent4.5mmd 22mml wno dstl tp was partially inspected since part of the device was stuck inside the received microcatheter.The delivery wire was inspected, and it was found stuck inside the received microcatheter at 68 cm.The introducer was inspected, and it was found in good normal conditions.The microcatheter was inspected under x-ray in order to verify if the stent was attached to the delivery wire, the x-ray analysis shows that the stent is stuck inside the microcatheter.The functional test could not be performed due the eu ent4.5mmd 22mml wno dstl tp was stuck inside the microcatheter.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 11151397.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The complaints reported by the customer ¿stent - deployment difficulty-unable to¿ and ¿delivery wire withdrawal difficulty-unable to¿ was confirmed, since during the analysis it was found that the eu ent4.5mmd 22mml wno dstl tp was stuck inside the microcatheter.The stuck condition noted on the eu ent4.5mmd 22mml wno dstl tp is related with the costumer complaint and may have appeared to have been caused by insufficient flushing.The condition in which the device was received suggest an incorrect preparation of the device for use, since per instructions for use (ifu) of the enterprise device, the distal end of the introducer must be partially inserted into the rhv connected to the infusion catheter, then tighten the locking ring and flush the y-connector of the rhv with sterile saline and verify that fluid exits the proximal end of the introducer.However, the eu ent4.5mmd 22mml wno dstl tp is stuck inside the microcatheter but there is no rhv connected to the microcatheter.Neither the analysis nor the mre suggest that the failure reported by the costumer could be related to the manufacturing process.No corrective action will be taken at this time.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.

• Brand Name: EU ENT4.5MMD 22MML WNO DSTL TP
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 9083716
• MDR Text Key: 160317207
• Report Number: 1226348-2019-00986
• 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: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2021
• Device Catalogue Number: ENC452200
• Device Lot Number: 11151397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN MICROCATHETER; UNKNOWN PROWLER SELECT MICROCATHETER