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

Catalog Number	1012631-29
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant products: sheath: 6f terumo, 8f terumo; stent: 8.0 x 29 mm omni elite vascular.Evaluation summary: visual inspection was performed on the returned device.Only the stent implant was returned dislodged from the delivery system.The stent dislodgment was likely due to anatomical conditions.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 revealed no other similar incidents.The investigation determined that the reported difficulties were due to case circumstances.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 procedure was to treat a lesion in the non-tortuous, heavily calcified 90% stenosed left common iliac artery.Following the successful deployment of an 8.0 x 29 mm omni elite vascular stent the physician decided to deploy another 8.0 x 29 mm otw omni elite vascular stent proximally.The omni elite vascular stent delivery system (sds) was advanced to the lesion and during deployment the stent implant dislodged from the balloon.The sds was removed from the anatomy.The 6f non-abbott introducer sheath was replaced with an 8f non-abbott introducer sheath and a snare device was used to retrieve the stent implant.The procedure was stopped at that point and they had to hold additional pressure on the access site to stop the bleeding.No additional information was provided.

• Brand Name: OMNILINK ELITE PERIPHERAL STENT SYSTEM
• Common Device Name: PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6488950
• Report Number: 2024168-2017-03114
• Device Sequence Number: 18985665
• Product Code: NIO
• UDI-Device Identifier: 08717648178504
• UDI-Public: (01)08717648178504(17)190930(10)6041441
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 1012631-29
• Device Lot Number: 6041441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2017
• Initial Report FDA Received Date: 04/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONCOMITANT MEDICAL DEVICES
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 82