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

Catalog Number	1012633-39
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.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 identified no other incidents from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation was unable to determine a conclusive cause for the reported difficulties; however the additional patient effect of surgical procedure appears to be related to circumstances of the procedure.
Event or Problem Description
It was reported the procedure was to treat a de novo lesion in the right external iliac artery.The lesion was pre-dilated with a 9.0 mm balloon catheter successfully.The 10 x 39 mm omnilink stent delivery system (sds) was advanced and deployed successfully.However, intravascular ultrasound (ivus) noted that the proximal end of the stent implant had folded over.A balloon catheter was advanced in an attempt to mend the stent, but the stent became mangled.A cut down emergency procedure had to be performed to extract the mangled stent from the patient anatomy.The vessel was treated with endarterectomy and completed with a patch.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: 6125703
• Report Number: 2024168-2016-08321
• Device Sequence Number: 10878906
• Product Code: NIO
• UDI-Device Identifier: 08717648178597
• UDI-Public: (01)08717648178597(17)180930(10)5042841
• 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
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/23/2016

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: 09/30/2018
• Device Catalogue Number: 1012633-39
• Device Lot Number: 5042841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2016
• Initial Report FDA Received Date: 11/23/2016
• 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: 61 YR
• Patient Weight: 105