MAUDE Adverse Event Report: AV-TEMECULA-CT SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number S-65-150-120-P6

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2015

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 received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported the procedure was to treat a de novo lesion with no tortuosity and heavy calcification in the superficial femoral artery.Pre-dilatation was performed with a 6 mm balloon and the supera was advanced to the lesion.Under fluoroscopy, the deployment lock was unlocked and the thumbslide was advanced to the most distal position on the handle; however, the stent partially deployed and was not fully implanted before the catheter was withdrawn.When the device was withdrawn from the patients anatomy, the stent was removed as well with the device.Another device was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned for evaluation and the reported deployment issue was not able to be confirmed as the stent had already been deployed.Based on visual analysis of the returned device, there is no indication of an issue/observation caused by, or related to the design, manufacture, or labeling of the device.A conclusive cause for the reported deployment difficulty could not be determined.There was additional damage to the device which was due to operational context.A review of the lot history record revealed no non-conformances that would have contributed to this event.A query of the electronic complaint handling database revealed no other incidents reported from this lot.Based on the information reviewed, there is no indication the issue was caused by, or related to the design, manufacture or labeling of the device.

• Brand Name: SUPERA 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
• Manufacturer (Section G): WEBSTER, TX USA REG#3005325609; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5287737
• MDR Text Key: 33767889
• Report Number: 2024168-2015-07459
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• 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,Followup
• Report Date: 01/19/2016

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: 03/31/2016
• Device Catalogue Number: S-65-150-120-P6
• Device Lot Number: 02299070
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2015
• Initial Date FDA Received: 12/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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: 77 YR
• Patient Weight: 98