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

Catalog Number 1012016-120

Device Problems Break (1069); Detachment Of Device Component (1104); Positioning Failure (1158); Mechanical Jam (2983)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 06/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The armada 18 device referenced is being filed under a separate medwatch manufacturer report reference number.

Event Description

It was reported that the procedure was to treat a moderately tortuous, heavily calcified de novo lesion in the mid femoral artery.A 4.0 x 40mm armada balloon dilatation catheter was advanced to the lesion, but air was noted as leaking from the catheter.Then a 7.0 x 120mm absolute pro stent-delivery system crossed the lesion without issue.During deployment, about 1/3 of the stent was partially deployed.The release mechanism got hard, resistance was felt until a break occurred, which consequently broke the stent in pieces.The stent was removed, but some pieces remained in the artery.Then three omnilink elite (ole) stents were used to treat the lesion.The physician had one of the ole stents deploy over the portion of the absolute pro stent that remained in the artery.No additional information was provided.

Manufacturer Narrative

Internal file number: (b)(4).Evaluation summary: a visual inspection was performed on the returned device.The deployment failure and thumbwheel resistance were unable to be confirmed due to the condition of the returned device.The partial handle separation and stent separation were confirmed.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 of the reported lot revealed no indication of a lot specific issue.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the initially filed mdr report, the account confirmed that the leak for the armada balloon catheter was noted near the hub (outside of the anatomy).The device was simply removed without issue.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: ABSOLUTE PRO LL SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7639368
• MDR Text Key: 112410109
• Report Number: 2024168-2018-05046
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/01/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 1012016-120
• Device Lot Number: 7020361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Initial Date Manufacturer Received: 06/14/2018
• Initial Date FDA Received: 06/26/2018
• Supplement Dates Manufacturer Received: 10/01/2018
• Supplement Dates FDA Received: 10/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention