MAUDE Adverse Event Report: ABBOTT VASCULAR OMNILINK ELITE; PERIPHERAL STENT DELIVERY SYSTEM

Model Number	1012633-19
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.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 complaints.Based on the information provided, the reported difficulties and vessel damage appear to be due to circumstances of the procedure.The resistance during removal and stent dislodgement was due to interaction with the heavily tortuous and calcified vessel while attempting to withdraw the stent delivery system to exchange the guide wire.The reported patient effect of arterial injury (vessel damage) is listed in the omnilink elite instructions for use as a known potential complication associated with the use of the device.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the 10.0x19 mm omnilink elite stent delivery system (sds) successfully crossed the heavily tortuous, mildly calcified, right subclavian artery, but the guide wire that the sds was loaded on, was too stiff.The physician intended to switch out the guide wire to allow for correct positioning of the sds.During removal of the sds, resistance was felt with the anatomy and the stent began to come off the sds.The physician inflated the sds to two atmospheres to prevent the stent from fully dislodging.The sds was successfully retracted inside the 7 french sheath.During removal of the sheath and sds as a unit, the sheath came out first, while the sds was still in the body.The stent then dislodged from the sds in the iliac artery.The sheath introducer was used to advance the stent to the aorta so the snare could capture the dislodged stent.The snare was retracted into the sheath with difficulty and the devices were removed as a unit through the common femoral artery access.Intimal artery damage was noted at the common femoral, so balloon angioplasty was performed to successfully treat the damage.There was no perforation, no excess bleeding, and no flow limiting issues at the common femoral.The procedure was completed.No additional information was provided.

• Brand Name: OMNILINK ELITE
• Common Device Name: PERIPHERAL STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9682875
• Report Number: 2024168-2020-01294
• Device Sequence Number: 11547154
• Product Code: NIO
• UDI-Device Identifier: 08717648178573
• UDI-Public: 08717648178573
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 1012633-19
• Device Catalogue Number: 1012633-19
• Device Lot Number: 9060641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR