MAUDE Adverse Event Report: COOK IRELAND LTD UNKNOWN; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number UNKNOWN

Device Problem Obstruction of Flow (2423)

Patient Problem Occlusion (1984)

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # p100022/s027.Device evaluation: it should be noted that for the purpose of this file the investigation and risk assessment have been completed based on a zilver ptx thumbwheel (zisv6-ptx) device as the zilver ptx pin and pull (ziv6-ptx) devices are no longer manufactured.As per the complaint description, it is not confirmed that restenosis reoccurred within the zilver ptx stent.This investigation has been completed to cover the possibility that the re-occlusion could have occurred within this stent.The zilver ptx device unknown rpn and unknown lot number involved in this complaint was implanted in the patient, and was not available for evaluation.With the information provided, a document based investigation was conducted.Document review: as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all zisv6 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.Restenosis of the stented artery is listed as a known potential adverse event within the instructions for use (ifu0117-3).There is no evidence to suggest that the customer did not follow the instructions for use.The (b)(6) packaging insert supplied with the device complies with mhlw law no.84 of 2013 which avoids including information that is not specific to the medical device or that which is basic knowledge already understood by the healthcare professional, to ensure to accurately convey all the information that is important for the user.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient pre-existing conditions.From the information provided it is known that the patient is a smoker and has diabetes.The patient has a medical history of acute myocardial infarction and anterior abdominal aortic aneurysm.It is possible that the patient¿s pre-existing conditions and smoking habit may have contributed to this event.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patient required surgical thrombectomy with a fogarty catheter and transcatheter thrombolytic aspiration to resume blood flow as a result of this event.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

In this study, the physician performed stent graft (viabahn) implantation for acute limb ischemia due to popliteal aneurysm.However, restenosis repeated though zilver ptx was placed as an additional treatment.[update by (b)(6), (b)(6) 2019].(this description is the translation of the case report).Popliteal artery aneurysm is a relatively rare disease.It is often discovered with ischemic symptoms, and limb salvage for the case may be difficult.In the past, bypass surgery has been used to treat popliteal artery aneurysms, but in recent years reports of treatment with stent-graft placement have increased.In this study, the physician performed stent graft (viabahn produced by gore) implantation for acute limb ischemia due to popliteal aneurysm.However, restenosis repeated twice, so i will report the case as a reflection.[case] a (b)(6) male.Health history: the patient has smoking habit and diabetes.He experienced acute myocardial infarction (pci) 16 years ago, and anterior abdominal aortic aneurysm (artificial vascular replacement) 14 years ago.Current medical history: the patient complained the right lower limb pain.As the result of ct at another hospital, 33 x 33 x 90 mm fusiform aneurysm at the popliteal artery and lower leg artery occlusion were observed.Therefore, he was rushed to our hospital.[emergency surgery] the aneurysm was completely occluded, but the lower leg artery was slightly depicted.We decided to perform transcatheter treatment.Viabahn (gore¿s stent graft) 6 × 150, 7 × 100 was placed after a 0.014 micro catheter reached the distal part of the popliteal artery.A large amount of thrombus was found in the lower leg artery, and a revascularization was successfully conducted by transcatheter thrombolytic aspiration.The patient was discharged on the 5th postoperative day, but symptoms recurred during pilling up the weeds on the 8th postoperative day.Restenosis of viabahn was observed.Therefore, transcatheter thrombolytic aspiration removal was urgently performed, and a metal stent placement (zilverptx) was performed in viabahn.We recommended him bypass surgery, yet he wanted follow-up.10 months after the operation, restenosis occurred again while pruning the lower branches of the pine.Surgical thrombectomy with a fogaty catheter produced by edwards life science and transcatheter thrombolytic aspiration were performed, so the blood flow was resumed.Then, additional stent /smart produced by johnson & johnson was placed in viabahn.Since the patient¿s consent has been obtained, we are scheduled to perform palliative bypass surgery 1 month after the additional treatment. in the initial report on august 22, 2019, i wrote this sentence as a short summary :¿in this study, the physician performed stent graft (viabahn) implantation for acute limb ischemia due to popliteal aneurysm.However, restenosis repeated though zilver ptx was placed as an additional treatment.¿ however, it does not stick closely to the original.This is because there is no description that restenosis reappeared at the site where zilver ptx was placed.I described matters after the placement of zliver ptx in the translation of the case report in the update on (b)(6) 2019 as follows: ¿10 months after the operation, restenosis occurred again while pruning the lower branches of the pine.Surgical thrombectomy with a fogaty catheter produced by edwards life science and transcatheter thrombolytic aspiration were performed, so the blood flow was resumed.¿ this sentence does not clarify the causal relationship between zilver ptx and restenosis.Therefore, we can not decide that zilver ptx is related to the incident reported in this report case.¿ fda mdr reporting required: this event meets the criteria of an fda ¿serious injury¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.The patient will require a bypass procedure following restenosis.

• Brand Name: UNKNOWN
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: heather ryan ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 9081793
• MDR Text Key: 161926697
• Report Number: 3001845648-2019-00478
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/21/2019

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/21/2019
• Event Location: Hospital
• Date Manufacturer Received: 08/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR