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

Catalog Number 1012630-59

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

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

Event Date 11/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Patient age is estimated.Concomitant medical products: stents: 8.0x100x135 absolute pro; 7.0x59x135 omnilink elite.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.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effects of hypotension and perforation are known observed and potential patient effects as listed in the omnilink elite electronic instructions for use (ifu).Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The absolute pro device referenced is being filed under a separate manufacturing report number.

Event Description

It was reported that during the procedure to treat a heavily calcified chronic total occlusion in the left common iliac artery, a 8.0mmx100mmx135cm absolute pro self-expanding stent system (sess) was advanced without issue to the lesion.The device was unlocked without issue.As the sheath was being retracted during deployment, with no resistance felt, the stent appeared to be constricted as it was being released and it was slow to expand.The stent was ultimately able to be deployed in the target lesion, but a waist was noted in the stent.Post-dilatation was performed but the waist was still present.Thus, a 7.0mmx59mmx135cm omnilink elite balloon expandable stent system (bess) was advanced to the absolute pro, but the omnilink elite was unable to cross through the waist area of the deployed absolute pro to treat the waist.The omnilink elite stent was alternatively deployed, overlapping the proximal end of the absolute pro stent.Another same size omnilink elite stent was then advanced and crossed the absolute pro without difficulty and was deployed, successfully resolving the waist, but a perforation resulted.The patient became hypotensive which was resolved with medication.An attempt was made to cross the perforation with a non-abbott covered stent, but it was unable to cross.Balloon tamponade with an unspecified balloon successfully resolved the perforation and the patient was discharged in good condition with adverse patient sequelae.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: 6156500
• MDR Text Key: 61850988
• Report Number: 2024168-2016-08715
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648178481
• UDI-Public: (01)08717648178481(17)180630(10)5012841
• 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: 12/08/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 1012630-59
• Device Lot Number: 5012841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2016
• Initial Date FDA Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• 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): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 82