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

Catalog Number 1012629-19

Device Problems Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a lesion located in the right renal descending artery.The 6.0 mm/19 mm omnilink elite stent delivery system (sds) was advanced and the stent deployed without any issues.The sds was removed from the patient.The vessel was reaccessed with the guiding catheter, at which time the tip of the guiding catheter came into contact with the proximal end of the deployed stent that was protruding into the aorta and bent the stent.This did not cause any flow-limiting problems; therefore, no treatment was required.No adverse patient effects or clinically significant delay in the procedure were reported.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: 6381845
• MDR Text Key: 69499758
• Report Number: 2024168-2017-01846
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648179518
• UDI-Public: (01)08717648179518(17)160331(10)4102441
• 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: 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 1012629-19
• Device Lot Number: 4102441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2017
• Initial Date FDA Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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
• Patient Age: 71 YR
• Patient Weight: 75