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

Catalog Number 1012624-59

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001)

Event Date 08/25/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.There was no reported device malfunction and the product was not returned.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.The reported patient effects of hypotension and perforation, as listed in the omnilink elite, instructions for use, are known adverse events.Although a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined, there is no indication the issue was caused by, or related to the design, manufacture or labeling of the device.(b)(4).

Event Description

It was reported that the procedure was to treat a heavily tortuous and heavily calcified right iliac artery.The 8.0mmx59mmx80cm omnilink elite stent was deployed at 11 atmospheres (atm) and the procedure was completed without issue.The patient was taken to the holding room when his blood pressure dropped and when brought back to the cath lab, angiography revealed there was a perforation distal to the implanted abbott stent.Two 8 x 50 mm non-abbott stents were successfully used to treat the perforation.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: 5082949
• MDR Text Key: 25989957
• Report Number: 2024168-2015-05390
• Device Sequence Number: 1
• Product Code: NIO
• 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
• Report Date: 09/16/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 1012624-59
• Device Lot Number: 5042741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR