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

Catalog Number 1012625-29

Device Problems Entrapment of Device (1212); Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The product was not returned to abbott vascular for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Review of the complaint history identified no other similar incidents reported from this lot.The investigation determined the reported difficulties of entrapment of the device, stent dislodgement, stent damage, and patient effects appear to be related to circumstances of the procedure.The reported patient effects of hematoma and hemorrhage are listed in the omnilink elite stent instructions for use as known patient effects of stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.The other otw omni elite device referenced in describe event or problem and concomitant medical products is being filed under a separate medwatch mfr number.

Event Description

It was reported that this was a peripheral intervention to treat the heavily calcified iliac arteries.During advancement of the 9.0x29 mm omnilink elite stent delivery system (sds) through a 6 french sheath it was noted that the sds was advanced too far into the aorta.When the sds was pulled back to position in the iliac, the stent dislodged from the sds but remained on the guide wire.The procedure continued with deployment of the 9.0x39 omnilink elite stent in the iliac artery.The introducer sheath was up-sized to a 7 french sheath and a snare was inserted.The dislodged stent was pulled back with the snare; however, it interacted with the deployed 9.0x39 omnilink elite stent.The snare was removed and the stent was re-snared, but during retraction, it interacted with the deployed stent again.This time, the devices became stuck and the groin access site was bleeding, possibly from manipulation of the devices.Oxygen saturation was decreased from the blood loss.Pressure was held on the groin site and the procedure was stopped.Surgery was performed to remove the stuck devices (dislodged stent, snare, deployed stent) and perform a patch angioplasty procedure to treat the vessel.The patient tolerated the surgery and was in stable condition in the intensive care unit.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: 7534326
• MDR Text Key: 108924325
• Report Number: 2024168-2018-03805
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648179334
• UDI-Public: 08717648179334
• 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
• Report Date: 05/22/2018

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: 07/31/2018
• Device Catalogue Number: 1012625-29
• Device Lot Number: 5020341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2018
• Initial Date FDA Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• 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: OMNILINK ELITE 9.0X39
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Weight: 65