MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA PERIPHERAL STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number 42055200-120

Device Problems Difficult or Delayed Activation (2577); Material Deformation (2976)

Patient Problem Ischemia (1942)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a 5mm lesion in the superficial femoral artery with heavy calcification and moderate tortuosity.A 6f 11 cm sheath was placed and the lesion was prepped with a 5mm armada 35 percutaneous transluminal angioplasty (pta) balloon catheter inflated to 12 atmospheres for 90 seconds.On deployment of a 5.5 x 200 mm supera self expanding stent, the stent was noted to twist at the proximal portion [material deformation].Due to the diffuse lesion, some of the stent was implanted in healthy tissue.The stent was post dilated with an unspecified 6mm balloon catheter; however, this failed to untwist the stent.Pseudo [slow] flow was established between the stent struts and as a result no further intervention has been planned.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The reported patient effect of ischemia is listed as potential patient effect associated with the use of the device and is listed in the supera instruction for use.Images were provided and reviewed by a senior clinical research analyst.It was concluded that the images provided confirmed what appears to be a twist in the deployed supera stent.Based on the information provided and medical review of the returned images, a conclusive cause for the reported stent malformity, difficulty deploying, and subsequent patient effects could not be determined.It may be possible that the stent malformity and difficulty deploying was due to anatomical conditions which were described as heavy calcification and moderate tortuosity; however, this could not be confirmed.The additional therapy/non-surgical treatment was due to case circumstances as the stent was post dilated with an unspecified balloon catheter.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: SUPERA PERIPHERAL STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8942560
• MDR Text Key: 155936810
• Report Number: 2024168-2019-11310
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 42055200-120
• Device Lot Number: 9030461
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6F 11CM INTRODUCER SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 40