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

Catalog Number S-50-060-120-P6

Device Problems Detachment Of Device Component (1104); Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2017

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 that the procedure was to treat a 90% stenosis in the mid right superficial femoral artery (sfa) with no tortuosity and moderate calcification.Pre-dilatation was performed with a 5.0 x 60 mm armada 35 balloon dilatation catheter (bdc) at 8 atmospheres.A 6f, 65 cm guiding sheath was inserted in the left femoral artery and a 5 x 60 mm 6f supera stent delivery system (sds) was advanced on a ht connect guide wire to the lesion.When the stent was deployed, it deployed in the sheath.The sds was pulled out of the sheath, but the nosecone separated from the catheter.The stent and the nosecone remained inside the sheath.A 6f standard length guiding sheath (shorter than the first sheath) was inserted in the right femoral artery and a 5.5 x 60 mm 6f supera stent was successfully deployed in the lesion.It was stating that the first sheath remained in the left femoral access site until the procedure was completed and both guiding sheaths were removed at the same time.It was confirmed that the stent and nosecone were inside the sheath and there were no pieces of the device left inside the anatomy.The physician concluded that the 6f 65 cm sheath initially used was too long.There were no adverse patient effects or clinically significant delay in the procedure reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual inspection was performed on the returned device.The tip separation was confirmed.The deployment difficulties were unable to be confirmed as the stent had already been fully deployed.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 of the reported lot revealed no other incidents.The evaluation determined that the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect 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): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 6616838
• MDR Text Key: 76860853
• Report Number: 2024168-2017-04833
• 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: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: S-50-060-120-P6
• Device Lot Number: 6100461
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• 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