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

Catalog Number 11005-59

Device Problems Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem Perforation (2001)

Event Date 06/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical product: sheath: cordis brite tip 6f.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.The additional omnilink referenced is being filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat a mildly tortuous, mildly calcified common iliac artery through a kissing balloon stent technique.Two omnilink elite 35 stent delivery systems (sds) (9.0 x 39mm and 9.0 x 59mm) were attempted to be advanced through a non-abbott 6f sheaths.However, the physician was unable to introduce them through the sheaths and consequently unable to pull them out.The sheaths and the sds were pulled out together at the same time.Due to this and the obese condition of the patient, a rupture of one side of the artery was caused.Open surgery was performed.On the other side of the artery, an angioseal vessel closure system was used so that the patient may be moved to the operating room.The patient is doing well.There was no adverse patient sequela reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: a visual, dimensional and functional inspection were performed on the stent delivery system (sds).The reported difficulty to position and remove were confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other similar incidents reported for the lot.The investigation was unable to determine a conclusive cause for the reported difficulty to position and remove.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 initially filed mdr report, the account confirmed that the 9.0x39mm omnilink stent was not returned as it got stuck in the sheath during advancement, and consequently dislodged and remained there.The sheath was discarded.Additionally, it was confirmed that the stent did not remain in the anatomy.No additional information was provided.

• 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: 7617353
• MDR Text Key: 111610908
• Report Number: 2024168-2018-04656
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 11005-59
• Device Lot Number: 8022341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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