MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number UNKNOWN

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

The 510(k) number: p100022/s014.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Dr.(b)(6) was placing an 8 mm of unknown length zptx stent (off label), during an after-hours case.I was not present for the case.He mentioned he had difficulty a zptx and that the stent migrated into the aorta while he was attempt to place it in the iliac artery.He stated the stent fractured and he had to surgically remove it.He was walking into a procedure when he made me aware and i asked him to discuss further as i would need to call the complaint into cook.He said we would follow-up but after multiple attempts to discuss the failure he eluded me.Later that evening, i was hosting a dinner with other members from his group with my rbm, (b)(6) (cook aaa), and (b)(6) (field support manager).Dr.(b)(6), vascular surgeon partner of dr.(b)(6), made me aware that the event was not a result of fault of the product.He stated that dr.(b)(6) mal-placed the stent and later had to convert to open surgery for other reasons.While performing the open portion of the procedure, he decided to attempt to excise the ptx.Dr.(b)(6) stated dr.(b)(6) pulled the stent apart with surgical instruments and dr.(b)(6) was surprised by how easily the stent fractured.Dr.(b)(6) stated he explained to dr.(b)(6) that the ses are not designed to withstand the force he was placing on the product." additional information provided by (b)(6) on 28aug2018: "procedure was completed with open surgical repair.

Event Description

Dr.Kirby was placing an 8mm of unknown length zptx stent (off label), during an after-hours case.I was not present for the case.He mentioned he had difficulty a zptx and that the stent migrated into the aorta while he was attempt to place it in the iliac artery.He stated the stent fractured and he had to surgically remove it.He was walking into a procedure when he made me aware and i asked him to discuss further as i would need to call the complaint into cook.He said we would follow-up but after multiple attempts to discuss the failure he eluded me.Later that evening, i was hosting a dinner with other members from his group with my rbm, (b)(6), marcus carr (cook aaa), and andrea balkcom (field support manager).Dr.(b)(6), vascular surgeon partner of dr.(b)(6), made me aware that the event was not a result of fault of the product.He stated that dr.Kirby mal-placed the stent and later had to convert to open surgery for other reasons.While performing the open portion of the procedure, he decided to attempt to excise the ptx.Dr.Williamson stated dr.Kirby pulled the stent apart with surgical instruments and dr.Kirby was surprised by how easily the stent fractured.Dr.Williamson stated he explained to dr.Kirby that the ses are not designed to withstand the force he was placing on the product." additional information provided by dm on (b)(6) 2018: "procedure was completed with open surgical repair.

Manufacturer Narrative

510(k) number: p100022/s014.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: ed sutkowski, cook medical incorporated (cmi), 1025 acuff road, p.O box 4195, bloomington, indiana , 47402-4195.Importer site establishment registration number: 3005580113.Device evaluation the zilver ptx device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.It may be noted that the sales rep could not obtain any further information from the physician who performed this procedure.As a result no further information regarding stent migration could be obtained.There is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.From the information provided the most likely root cause for this complaint is the off-label use (mal-placement) of the stent.The placement of the stent in an area that is not indicated could have resulted in the stent migrating to the aorta.The stent later fractured as the physician attempted to remove it from the aorta as a result of the migration.However, as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.It may be noted that the instructions for use state the following: ¿the zilver ptx drug eluting stent is indicated for improving the luminal diameter for the treatment of de novo or restenotic symptomatic lesions in native vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameter from 4 mm to 7 mm and total lesion length up to 300 m per patient.¿ 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 zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity as per finished product q.C.Summary there is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.The risk was determined to be low/category iii.According to the initial reporter, the procedure was completed with open surgical repair.However, from the information provided, the physician had to convert to open surgery for reasons other than the mal placed stent.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7884795
• MDR Text Key: 120537526
• Report Number: 3001845648-2018-00432
• 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
• Type of Report: Initial,Followup
• Report Date: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/23/2018
• Event Location: Hospital
• Date Manufacturer Received: 08/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention