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

Catalog Number	1012629-59
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Patient weight is (b)(6).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 similar incidents reported from this lot.The investigation determined the reported difficulties to be related to the patient anatomical conditions.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 heavily calcified, de novo lesion in the non-tortuous, but tight, proximal left common iliac artery.A 6.0mm x 59mm x 135cm omnilink elite vascular balloon expandable stent system was advanced over a 0.035 non-abbott guide wire and to the target lesion without resistance.When verifying stent position under fluoroscopy, it was noted that the omnilink elite system had inadvertently been advanced past the target lesion into the distal left common iliac.When pulling the omnilink elite system back toward the proximal iliac target lesion, resistance was felt against the lesion calcification, but no force was applied, and the stent dislodged in the distal iliac.The omnilink elite delivery system was withdrawn from the anatomy without difficulty.Unspecified 3.0mm then 4.0mm balloons were each advanced into the unexpanded omnilink elite stent, and the balloons were each inflated, gradually pulling the stent back into the target lesion.An unspecified 6.0mm balloon was then advanced and the omnilink elite was successfully deployed in the target lesion.There were no adverse patient sequelae and no occurrence of a clinically significant delay.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: 6534423
• Report Number: 2024168-2017-03806
• Device Sequence Number: 16431278
• Product Code: NIO
• UDI-Device Identifier: 08717648179549
• UDI-Public: (01)08717648179549(17)190630(10)6011841
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2017

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: 06/30/2019
• Device Catalogue Number: 1012629-59
• Device Lot Number: 6011841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2017
• Initial Report FDA Received Date: 05/01/2017
• 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: GUIDE WIRE: 0.035 GLIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 47