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

Model Number G38490

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

Patient Problem Failure of Implant (1924)

Event Date 02/07/2019

Event Type  Injury  

Manufacturer Narrative

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

As reported to customer relations, "products failed to deploy correctly.Deployment issue.Coaxial system didn¿t moved seem very tight while scrolling back.While pulling first system out stent started coming out of catheter.Patient was ok.A stent was fracture and broke and left in patient, doctor angioplastied stent to wall in common femoral.No adverse effects.The second and third device felt tightness upon scrolling back, decided to remove device completely.Safely removed device, patient fine, no additional products.".

Event Description

As reported to customer relations, "products failed to deploy correctly.Deployment issue.Coaxial system didn¿t moved seem very tight while scrolling back.While pulling first system out stent started coming out of catheter.Patient was ok.A stent was fracture and broke and left in patient, doctor angioplastied stent to wall in common femoral.No adverse effects.The second and third device felt tightness upon scrolling back, decided to remove device completely.Safely removed device, patient fine, no additional products." 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)¿ section 2.13 and 2.15.After the stent fractured an angioplasty was required.Also reportable under the following precedences: thumbwheel malfunctions during deployment stent fracture deployment difficulty resulting in partial stent deployment.This complaint report does not meet the requirements of an adverse reaction/device defect report as per 21 cfr part 814.82 (a)(9).

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 mfr site as follows: importer site contact and address: (b)(6).(b)(4).Device evaluation two additional files have been opened in relation to this pr.For details of the other investigations please refer to pr 254370 and pr 254371.The zisv6-35-125-7-120-ptx device of lot number: c1487142 involved in this complaint was returned for evaluation without its original packaging.With the information provided, a physical examination and a document based investigation was conducted.Lab evaluation the device related to this occurrence underwent a laboratory evaluation on the 28th march 2019.Significant crinkling was observed on the stability sheath (ss) and stent retraction sheath (srs).The srs was not retracting as the retraction wire was separated from the srs.Approximately 30.0 mm of the stent was missing.As per the complaint description, the stent fractured on removal of the device and the fractured piece was angioplastied to the vessel wall.Document review prior to distribution zisv6-35-125-7-120-ptx 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.A review of the manufacturing records for zisv6-35-125-7-120-ptx of lot number: c1487142 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number: c1487142.The instructions for use states the following: ¿do not use excessive force to deploy the stent.If excessive resistance is felt when beginning deployment, remove the delivery system without deploying the stent and replace with a new device.¿ root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to difficult patient anatomy.From the information provided it is known that the patient exhibited tortuous and calcified anatomy.Difficult patient anatomy could have caused and/or contributed to high forces being exerted on the stent retraction sheath (srs) as the thumbwheel was rotated which could have caused and/or contributed to resistance or tightness as the thumbwheel was rotated resulting in the separation of the retraction wire from the srs.Separation of the retraction wire from the srs resulted in the partially deployed stent fracturing during device withdrawal.Summary: the complaint is confirmed as the failure was confirmed in the laboratory.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

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: (b)(6).Cook medical incorporated (cmi) (b)(4).Importer site establishment registration number: (b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

As reported to customer relations, "products failed to deploy correctly.Deployment issue.Coaxial system didn¿t moved seem very tight while scrolling back.While pulling first system out stent started coming out of catheter.Patient was ok.A stent was fracture and broke and left in patient, doctor angioplastied stent to wall in common femoral.No adverse effects.The second and third device felt tightness upon scrolling back, decided to remove device completely.Safely removed device, patient fine, no additional products." 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)¿ section 2.13 and 2.15.After the stent fractured an angioplasty was required.Also reportable under the following precedence's: thumbwheel malfunctions during deployment; stent fracture; deployment difficulty resulting in partial stent deployment.This complaint report does not meet the requirements of an adverse reaction/device defect report as per 21 cfr part 814.82 (a)((9).

• 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: 8394415
• MDR Text Key: 137948873
• Report Number: 3001845648-2019-00089
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384900
• UDI-Public: (01)10827002384900(17)200321(10)C1487142
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2020
• Device Model Number: G38490
• Device Catalogue Number: ZISV6-35-125-7-120-PTX
• Device Lot Number: C1487142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/07/2019
• Event Location: Hospital
• Date Manufacturer Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention