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

Catalog Number 1012622-19

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2016

Event Type  malfunction  

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 relevant information.The 7.0 mm x 19 mm x 80 cm omnilink elite referenced is being filed under separate medwatch report.

Event Description

It was reported the procedure was to treat a lesion in the celiac and superior mesenteric arterial (sma) trunk.The 7.0 mm x 19 mm x 80 cm omnilink elite stent was successfully deployed in the celiac trunk without issue.A 6.0 mm x 19 mm x 80 cm omnilink elite balloon expandable stent system was inserted in the sma, however during insertion in the sma the second omnilink stent strut got caught on the deployed stent.It would not become untangled with catheter maneuvers or inflation.The 6.0 mm x 19 mm x 80 cm omnilink stent had to be deployed inside of the guide catheter to try to get it to untangle from the strut of the previously placed stent, however this did not work, both stents remained attached.The guiding catheter was removed with the 6.0 mm x 19 mm x 80 cm omnilink stent inside of it.As the guide catheter was removed, the 7.0 mm x 19 mm x 80 cm omnilink stent in the celiac trunk became mangled and was explanted as it was still entangled with the omnilink stent inside the guide catheter.The procedure was discontinued.There were no adverse patient effects.Although there was a delay in the procedure it did not result in significant impact to the patient.The patient will have to return for angioplasty and stenting.No additional information was provided.

Manufacturer Narrative

(b)(4).Correction: it was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded and is not available for evaluation.The device was not returned for evaluation.In this case, the reported difficulties occurred due to interaction with the previously deployed stent.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 reported from this lot.The investigation determined that the reported difficulties were due to operational context.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 6178819
• MDR Text Key: 62699115
• Report Number: 2024168-2016-08911
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 1012622-19
• Device Lot Number: 6012841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 12/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2016
• 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
• Treatment: STENT: 7.0 MM X 19 MM X 80 CM OMNILINK ELITE
• Patient Age: 87 YR