MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX DRUG-ELUTING PERIPIHERAL STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DURG-ELUTING

Catalog Number ZIV6-35-125-6.0-120-PTX

Device Problems Positioning Failure (1158); Fracture (1260)

Patient Problems Reocclusion (1985); Surgical procedure, additional (2564)

Event Date 04/24/2014

Event Type  Injury  

Event Description

On (b)(6) 2012, ziv6-35-125-6.0-120-ptx / c777371 x in the left proximal sfa + ziv6-35-125-6.0-120-ptx / c775581 x 1 in the left distal sfa + ziv6-35-125-6.0-120-ptx / c775582 x 1 in the left middle sfa were placed with cross-over approach from the right groin.There were no calcifications or tortuosity observed in the access route.During the procedure, 1 x ziv6-35-125-6.0-120-ptx stent could not be deployed due to elongated delivery system and the partially deployed stent fractured.The broken ziv6-35-125-6.0-120-ptx / c777371 x 1 was placed in the left proximal sfa and its separated segment in the dfa.(this even has previously been investigated).On (b)(6) 2014, occlusion in the 3 stents excluding the previously fractured ziv6-35-125-6.0-120-ptx / c777371 x 1 was confirmed.According to the physician, it seemed that all the 3 stent were stenosed diffusely first, then occluded due to thrombosis which developed in the especially narrowed segment.Pta and thrombectomy were performed.On (b)(6) 2014, the patient had a favorable outcome.

Manufacturer Narrative

Udi #: (b)(4).This report relates to 1 x ziv6-35-125-6.0-120-ptx.Reference also related reports 3001845648-2014-00207, 00208.The ziv6-35-125-6.0-120-ptx stent of lot number c777371 was implanted in the patient; therefore, is not available for evaluation.With the information provided a document based investigation was carried out.According to additional information provided for in this complaint, long cto (chronic total occlusion) was listed as a factor that could have contributed to the event.In addition, worsened claudication was indicated as an adverse effect to the patient due to this occurrence.It may be noted that the re-stenosis is a common adverse event of endovascular procedures and can be caused by injury to the vessel (e.G.During pta and/or stenting).Vessel injury provokes an inflammatory response that leads (or amplifies) to the restenosis process.In relation to this event, the following comment were provided by physician: "the event is not related to previous adverse events [stent fracture]", "the event is thrombotic occlusion due to in-stent restenosis that is regarded as a different event from stent thrombosis".Based on the above, it can be stated that thrombotic occlusion most likely occurred due to poot blood flow due to in stent restenosis caused by intimal hyperplasia.It is known that intimal hyperplasia may result from endovascular procedures and is not infrequently seen after angioplasty, stent insertion, etc.Worsened claudication indicated in the additional information form is the symptom of occlusive arterial disease and can be associated with reported restenosis.It is unlikely that this event could have occurred due to zilver ptx malfunction, however, a definitive root cause of this stent restenosis cannot be determined.Although requested images relating to this event have not been provided.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.The complaint is confirmed based on customer testimony.Intimal hyperplasia was the most likely cause of in stent restenosis which ultimately resulted in thrombotic occlusion of the left sfa.According to information provided, pta and thrombectomy were performed and the patient had a favorable outcome.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPIHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DURG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: tracy o'sullivan ; 61334440
• MDR Report Key: 4213052
• MDR Text Key: 14874110
• Report Number: 3001845648-2014-00206
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2014
• Device Catalogue Number: ZIV6-35-125-6.0-120-PTX
• Device Lot Number: C777371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/24/2014
• Event Location: Hospital
• Date Manufacturer Received: 09/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2012
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR