MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC EU 4.5X22MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452212

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient age/date of birth, gender, weight, height, medical history, race, and ethnicity was not reported.Initial reporter: the customer contact information, including occupation, phone, and fax, was not reported.The product is available for evaluation and testing; however, it has not been received to date.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 manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report numbers are 1226348-2019-00988.

Event Description

As it was reported by a healthcare professional, during a stent-assist aneurysm embolization, the stent of a 4.5 x 22 mm enterprise (enc452212, 11142279) could not be withdrawn into the 150/5 cm prowler select plus microcatheter (606s255x, 30210853) though it deployed incompletely.When the catheter and stent arrived at the target position, the physician turned back the mc a lot and the stent deployed a lot.However, the physician thought the position where the stent deployed was not well enough.Then, he tried to withdraw the stent into the mc (pushed the catheter in the same time) to adjust the deployment position.But the physician found the stent ¿hard¿ to be withdrawn into the catheter.Only 4/5 of the stent was withdrawn to the catheter.The physician had to pull back the stent and mc together out of the patient¿s body, causing target position was lost.Another new stent and microcatheter from the same product code was used to complete the procedure.The new another catheter and stent was same code with the problem ones.There was no patient injury reported.Vascular detail position is +f2:n2.Additional information received indicated that the devices were inspected for damage prior to use and prepped as per the instructions for use (ifu).The stent had not been deployed beyond the recuperability limit listed in the instructions for use (ifu).No excessive force had been applied to the device.The mc did not kink or bend at any time.When the devices were removed from the patient, there were no damages on any part of the devices.Adequate flush had been maintained through the devices.There was no prolongation of procedure due to the event.The concomitant devices functioned as expected.The target vessel was reported as being tortuous.No additional intervention was needed to remove the devices from the patient.

Manufacturer Narrative

Product complaint (b)(4).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.

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 it was reported by a healthcare professional, during a stent-assist aneurysm embolization, the stent of a 4.5x22mm enterprise (enc452212, 11142279) could not be withdrawn into the 150/5cm prowler select plus microcatheter (606s255x, 30210853) though it deployed incompletely.When the catheter and stent arrived at the target position, the physician turned back the mc a lot and the stent deployed a lot.However, the physician thought the position where the stent deployed was not well enough.Then, he tried to withdraw the stent into the mc (pushed the catheter in the same time) to adjust the deployment position.But the physician found the stent ¿hard¿ to be withdrawn into the catheter.Only 4/5 of the stent was withdrawn to the catheter.The physician had to pull back the stent and mc together out of the patient¿s body, causing target position was lost.Another new stent and microcatheter from the same product code was used to complete the procedure.The new another catheter and stent was same code with the problem ones.There was no patient injury reported.Vascular detail position is +f2:n2.Additional information received indicated that the devices were inspected for damage prior to use and prepped as per the instructions for use (ifu).The stent had not been deployed beyond the re-capurability limit listed in the instructions for use (ifu).No excessive force had been applied to the device.The mc did not kink or bend at any time.When the devices were removed from the patient, there were no damages on any part of the devices.Adequate flush had been maintained through the devices.There was no prolongation of procedure due to the event.The concomitant devices functioned as expected.The target vessel was reported as being tortuous.No additional intervention was needed to remove the devices from the patient.A non-sterile eu 4.5x22mm stent 12 mm dw tip was received inside of a pouch.The eu 4.5x22mm stent 12 mm dw tip was found partially inside of the received prowler select plus 150/5cm microcatheter (mc).The eu 4.5x22mm stent 12 mm dw tip was inspected.The delivery wire was found partially inside of the received mc and no damage was noted on it.The introducer was not received for evaluation.The stent was inspected, and it was found in good conditions but with some residues of biological material were found on it.The received mc was flushed using a lab sample syringe.After that, the unit the eu 4.5x22mm stent 12 mm dw tip was move through the received mc and it advance, a slight resistance/friction was felt.When the stent could pass through the received mc some residues of biological material was found on it.The stent was able to return inside the mc without difficulty.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 11142279.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¿ was not able to be confirm due that on the functional test, a slight resistance friction was felt when the enterprise was move through the received mc.But the stent was able to return inside the mc without difficulty.The device did not present any obvious indication of manufacturing defect or anomaly that could contributed to the event as reported.The condition (biological material) noted on the stent may have contributed to the failure and may have be related with an insufficient flushing, however this cannot be conclusively determined.Assignment of root cause for the event remains speculative and inconclusive, based on the information provided.However, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size and vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.Per the instructions for use (ifu), the stent may be recaptured until the point where the proximal end of the stent positioning marker is aligned with the infusion catheter distal markerband (re-capturability limit).If stent repositioning is required, gently advance the infusion catheter over the deployed stent (do not pull the stent back into the infusion catheter), reposition the system, and re-deploy the stent in the new location.Note: when advancing the infusion catheter over the stent during recapture, it may be necessary to keep the stent stable with tension on the delivery wire.Caution: if resistance is felt while recapturing the stent, do not continue to recapture the device.Withdraw the infusion catheter slightly to unsheathe the stent (without exceeding the recapture limit), and then attempt recapture the stent again.Caution: the stent may be fully recaptured once.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 4.5X22MM STENT 12 MM DW TIP
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 9106720
• MDR Text Key: 159935206
• Report Number: 1226348-2019-00987
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2021
• Device Catalogue Number: ENC452212
• Device Lot Number: 11142279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 09/23/2019
• Supplement Dates Manufacturer Received: 09/23/2019; 10/22/2019
• Supplement Dates FDA Received: 10/08/2019; 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS 150/5CM