MAUDE Adverse Event Report: SHAPE MEMORY MEDICAL IMPEDE EMBOLIZATION PLUG; VASCULAR EMBOLIZATION PLUG

Model Number IMP-10

Device Problem Activation Failure (3270)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/16/2021

Event Type  malfunction  

Event Description

The reported date of the incident is (b)(6) 2021, although the initial procedure took place on (b)(6) 2021.(b)(6) 2021: a 2-debranch tevar was being performed using a valiant captivia stent graft from medtronic, and an imp-10 was used to embolize the left subclavian artery at the same time.The left subclavian artery was measured to be 8-9 mm diameter.The imp-10 was introduced into the body from the left upper arm using an optimo guiding catheter from tokai medical products and delivered into the target site using an impress diagnostic catheter from merit medical.During the surgery it was reported that the anchor coil was not coiled and was an irregular shape when the embolization plug was delivered.Contrast enhanced ct was performed and the surgery was completed, although it was not confirmed at that time that embolization of the subclavian was achieved with the imp-10 device.(b)(6) 2021: during the post-operative examination using contrast enhanced ct a type ii endoleak was found from the left subclavian artery (lsca).(b)(6) 2021 in order to treat the type ii endoleak found during post-operative follow up, additional embokic coil devices (i.E.5 interlock coils from boston scientific) were deployed at the junction between the valiant captivia stent graft and the impede embolization plug.It was confirmed that the type ii endoleak had disappeared and the surgery was completed.

Manufacturer Narrative

The impede embolization plug was used to treat the left subclavian artery during a 2-debranch tevar.A review of the lot history record and accompanying lot release test report identified no quality issues related to device performance.The plug was unable to be returned as it was implanted in the patient.The chosen plug size was within the recommended vessel diameter range per the impede ifu.A definitive root cause cannot be established at this time based off of the information provided by the complainant.A supplemental report will be filed should additional information be received from the complainant.Note: the physician noted that the anchor coil component on the impede device deployed in an irregular shape.The anchor coil is not specified to coil in any specific pattern, however it coiled differently from what the physician expected.This did not appear to have an impact on device performance or the patient.

Event Description

The reported date of the incident is 16-sep-2021, although the initial procedure took place on (b)(6) 2021.(b)(6) 2021: a 2-debranch tevar was being performed using a valiant captivia stent graft from medtronic, and an imp-10 was used to embolize the left subclavian artery at the same time.The left subclavian artery was measured to be 8-9 mm diameter.The imp-10 was introduced into the body from the left upper arm using an optimo guiding catheter from tokai medical products and delivered into the target site using an impress diagnostic catheter from merit medical.During the surgery it was reported that the anchor coil was not coiled and was an irregular shape when the embolization plug was delivered.Contrast enhanced ct was performed and the surgery was completed, although it was not confirmed at that time that embolization of the subclavian was achieved with the imp-10 device.(b)(6) 2021: during the post-operative examination using contrast enhanced ct a type ii endoleak was found from the left subclavian artery (lsca).(b)(6) 2021: in order to treat the type ii endoleak found during post-operative follow up, additional embokic coil devices (i.E.5 interlock coils from boston scientific) were deployed at the junction between the valiant captivia stent graft and the impede embolization plug.It was confirmed that the type ii endoleak had disappeared and the surgery was completed.

Manufacturer Narrative

Anchor coil shape: case pictures and videos after the procedure on (b)(6) 2021 were sent by a cosmotec representative showing the implanted imp-10 in the target vessel; based on the pictures and videos, the shape of the anchor coil in the target vessel is not abnormal from that seen in impede devices used in previous cases.Differences in target vessel size and anatomy means that the anchor coil shapes in different random patterns, and it is never expected or specified that the device deploy in a neat loop.These differences in coiling patterns do not cause an issue with performance, as the coil still provides the necessary migration resistance in the target vessel.Foam deployed into anchor coil: case pictures and videos after the procedure on (b)(6) 2021 were sent by a cosmotec representative showing the implanted imp-10 in the target vessel; based on these pictures and videos, it appears that the foam portion of the device may have been pushed into the anchor coil which is not advised in the instructions for use.This can happen due to the fact that the plug is pushed by a guidewire interfacing with the proximal end of the foam (markerband side) and the coil portion of the implant exits the catheter first.After the coil exits the catheter, according to the ifu the user should stop forward advancement and deploy the plug portion by unsheathing or pulling back the delivery catheter instead.Please refer to ifu, step 12 in the directions for use which states that "forward advancement of the crimped smp plug may lead to incomplete expansion of the device if captured within the anchor coil; caution: forward advancement of the crimped smp plug may lead to incomplete expansion of the device if captured within the anchor coil." therefore, when the foam is lodged in the anchor coil this can prevent it from fully expanding and effectively occluding the target vessel.However due to the fact that the foam is translucent during imaging, this scenario cannot be definitively confirmed.The markerband is typically used to identify the location of the foam as it is attached to the proximal end, however it is not evident from the imaging provided where this is located.We hypothesize that the foam may be deployed within the anchor coil based on the position of the anchor coil, our understanding of the device construction, and the procedural details received.An event like this requires the physician to implant additional embolization devices to occlude the blood flow.The ifu steps 14 and 15 state "wait a minimum of five (5) minutes after device deployment to verify embolization and device expansion has occurred via angiography.If embolization is not observed, wait another five (5) minutes to verify embolization." the physician for this case used contrast enhanced ct to confirm that the embolization plug was delivered to the target site before completing the surgery but did not wait to confirm that embolization was achieved.The type ii endoleak was discovered a week later during the post-operative examination, resulting in an additional intervention two (2) weeks after the original treatment date to address the endoleak with additional embolic coil devices.

• Brand Name: IMPEDE EMBOLIZATION PLUG
• Type of Device: VASCULAR EMBOLIZATION PLUG
• Manufacturer (Section D): SHAPE MEMORY MEDICAL; 807 aldo avenue; suite 109; santa clara CA 95054 2252
• Manufacturer (Section G): SHAPE MEMORY MEDICAL; 807 aldo ave.; suite 109; santa clara CA 95054 2254
• Manufacturer Contact: meghan reu ; 807 aldo avenue; suite 109; santa clara, CA 95054-2254 ; 4086495175
• MDR Report Key: 12666698
• MDR Text Key: 284190002
• Report Number: 3013353964-2021-00002
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: B054IMP101
• UDI-Public: B054IMP101
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K181051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2021
• Device Model Number: IMP-10
• Device Catalogue Number: IMP-10
• Device Lot Number: F19112501
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: VALIANT CAPTIVIA STENT GRAPH FROM MEDTRONIC; VALIANT CAPTIVIA STENT GRAPH FROM MEDTRONIC
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian