MAUDE Adverse Event Report: AV-TEMECULA-CT OMNILINK ELITE PERIPHERAL STENT SYSTEM

Catalog Number 11004-59

Device Problems Difficult To Position (1467); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problem Tissue Damage (2104)

Event Date 03/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the omnilink elite became stuck in the 6fr sheath and it could not move forward.The device was pulled back and then the stent came off the balloon; partly in the anterior common femoral artery and in the sheath.The entire unit was to be removed from the patient; however, the stent became loose and it got stuck in the anterior common femoral artery and the skin.The anterior common femoral artery was torn and bleeding requiring a long term compression to achieve hemostasis.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual and dimensional inspections were performed on the returned device.The reported dislodgement of the stent implant was confirmed although the reported difficult to position and difficult to remove was unable to be confirmed as it was based on operational circumstances of the procedure.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported difficulties, foreign body removal of infection and patient effect of tissue damage appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the initial medwatch report the following information was provided: the dislodged stent was removed from the patient by pulling it out by hand; no intervention.The estimated compression time was 30-45 minutes.The patient was admitted and observed for 24 hours with no complications.

• Brand Name: OMNILINK ELITE PERIPHERAL STENT SYSTEM
• Type of Device: PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6457279
• MDR Text Key: 71682821
• Report Number: 2024168-2017-02796
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 11004-59
• Device Lot Number: 6071841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2017
• Initial Date FDA Received: 04/04/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• 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