MAUDE Adverse Event Report: AV-TEMECULA-CT ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number	1012536-100
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2016
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 age is estimated.The device was not returned for analysis.The investigation was unable to determine a conclusive cause for the reported slow deployment of the stent and waist appearance of the stent; however the failure to cross and treatment appear to be related to the circumstances of the procedure.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 2nd omnilink elite device referenced is being filed under a separate manufacturing report number.
Event or Problem 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: ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
• Common Device Name: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6156481
• Report Number: 2024168-2016-08712
• Device Sequence Number: 1003315
• Product Code: NIO
• UDI-Device Identifier: 08717648176173
• UDI-Public: (01)08717648176173(17)190630(10)6072561
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 1012536-100
• Device Lot Number: 6072561
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2016
• Initial Report FDA Received Date: 12/08/2016
• 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: 75 YR
• Patient Weight: 82