MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENTERPRISE2 4MMX23MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR402312

Device Problems Break (1069); Device Damaged by Another Device (2915)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/30/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth was not provided.The 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.A photo of the complaint device was included in the complaint.Product analysis lab reviewed the photo.Based on the photo, only part of the stent was observed.The photo is blurry and due to the blurriness, it could not be determined if the stent has any damage.Further investigation will be performed when the device is returned for investigation.(b)(6) performed a review of the device history records relative to the manufacturing, inspection and packaging of the lot#: 11209896.The history record indicates this product was final inspection tested at lake region medical, and was determined to be acceptable.This is one of 2 products involved with the reported complaint.The associated manufacturer report number is 3008114965-2020-00511.The manufacturer will submit a supplemental report if new facts arise, which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

The healthcare professional reported that during an aneurysmal intervention procedure in the (b)(6)-year-old female patient with a history of coronary heart disease.The target was at the right internal carotid artery (ica); the vessel was without abnormality and without excessive bending, the 4.0mm x 23mm enterprise® 2 vascular reconstruction device ((b)(4)) could not advance within the 150cm prowler select plus microcatheter (606s255x / lot# unknown).There was resistance between the stent,, and the microcatheter during advancement through the mid part of the microcatheter.Adequate, and continuous flush was maintained through the microcatheter.The physician withdrew the stent system from the patient an found that the stent was a little damaged; there was no damage to the stent prior to the reported resistance encountered.Additional information received indicated that the resistance was inside the microcatheter; there was no evidence of any physical obstruction within the microcatheter, the stent can be removed from the microcatheter after the microcatheter was removed from the patient¿s body.There was no appearance of damage on the microcatheter when it was removed; the stent was a little damaged inside the microcatheter.It was reported that the concomitant synchro® guidewire (stryker) was introduced through the microcatheter without any issue prior the issue with the enterprise stent.It was not known if the same prowler select plus microcatheter was used to complete the procedure.The procedure was completed with a new 4.0mm x 23mm enterprise® 2 vascular re-construction device.There was no report of any patient adverse event or complication.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during an aneurysmal intervention procedure in the 70-year-old female patient with a history of coronary heart disease; the target was at the right internal carotid artery (ica); the vessel was without abnormality and without excessive bending, the 4.0mm x 23mm enterprise® 2 vascular reconstruction device (encr402312 / 11209896) could not advance within the 150cm prowler select plus microcatheter (606s255x / lot# unknown).There was resistance between the stent and the microcatheter during advancement through the mid part of the microcatheter.Adequate and continuous flush was maintained through the microcatheter.The physician withdrew the stent system from the patient an found that the stent was a little damaged; there was no damage to the stent prior to the reported resistance encountered.Additional information received indicated that the resistance was inside the microcatheter; there was no evidence of any physical obstruction within the microcatheter, the stent can be removed from the microcatheter after the microcatheter was removed from the patient¿s body.There was no appearance of damage on the microcatheter when it was removed; the stent was a little damaged inside the microcatheter.It was reported that the concomitant synchro® guidewire (stryker) was introduced through the microcatheter without any issue prior the issue with the enterprise stent.It was not known if the same prowler select plus microcatheter was used to complete the procedure.The procedure was completed with a new 4.0mm x 23mm enterprise® 2 vascular reconstruction device.There was no report of any patient adverse event or complication.On 04 december 2020, the complaint device was received in the product analysis lab.The investigation has been completed.The documented findings are included below.Investigation summary: the non-sterile 4.0mm x 23mm enterprise® 2 vascular reconstruction device was received contained in a pouch.Visual inspection was performed.The stent component was detached from the device and was observed in damaged condition.The delivery wire and the introducer were inspected and found to be in good condition.Prior to receiving the complaint device, a photo of it was included in the complaint.Product analysis lab reviewed the photo.Based on the photo, only part of the stent was observed.The photo is blurry and due to the blurriness, it could not be determined if the stent has any damage.The complaint device was returned, and the stent component was already detached from the device and was confirmed to be damaged.Functional analysis was precluded due to the stent component already in a detached state.Lake region medical performed a review of the device history records relative to the manufacturing, inspection and packaging of the lot 11209896.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.The complaint reported that the 4.0mm x 23mm enterprise® 2 vascular reconstruction device could not advance within the 150cm prowler select plus microcatheter during the procedure due to resistance between the stent and the microcatheter.The physician withdrew the stent and observed that it was a little damaged.The issue was confirmed based on the visual inspection performed on the stent component of the returned complaint device.Additional information indicated that prior to the encountered resistance, there was no damage on the stent.The cause of the resistance from the friction between the stent and the microcatheter resulted in the damaged observed on the stent component.Per the instructions for use (ifu), do not apply undue force if resistance is encountered at any point during stent manipulation.This could result in damage to the stent.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.Updated sections: g.3, g.6, h.2, h.3, h.6, and h.10.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 1226348-2020-00471 and 3008114965-2020-00511.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received by the product analysis lab on (b)(6) 2020.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.This supplemental report will also include correction to the codes in section h.6.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 1226348-2020-00471 and 3008114965-2020-00511.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.In the initial report, the following sections were left blank by mistake: h.6: health effect - impact code; h.6: health effect - clinical code; h.6: medical device problem code.In this supplemental report, the codes have been added to these fields.

• Brand Name: ENTERPRISE2 4MMX23MM
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 10856949
• MDR Text Key: 218702461
• Report Number: 1226348-2020-00471
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2022
• Device Catalogue Number: ENCR402312
• Device Lot Number: 11209896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS 150/5CM; SYNCHRO® GUIDEWIRE (STRYKER)
• Patient Age: 70 YR
• Patient Weight: 55