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

Catalog Number UNK SUPERA

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.No udi is being reported as the part and lot numbers were not reported.The armada 35 referenced is filed under a separate medwatch report number.Evaluation summary: a visual inspection was performed.The reported entrapment of the device with the balloon catheter was unable to be replicated in a testing environment as it was based on operational circumstances.A review of the electronic lot history record (elhr) and similar incident query for this product was not performed since the part and lot number were not reported.The investigation determined the reported difficulties and subsequent damage appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a chronic total occlusion of the right superficial femoral artery.The access site was the right common femoral artery.An unspecified supera stent was implanted at the lesion and post-dilatation was performed with a 7.0 x 200 mm armada 35 balloon dilatation catheter (bdc).The armada bdc did not meet any resistance during advancement; however, deflation time was insufficient and a waist occurred in the balloon because the distal part still had contrast inside it.The top half of the balloon deflated fast; however, removal of the balloon was started before the rest of the balloon had fully deflated.Therefore, the balloon separated into two separate pieces.Part of the balloon was inside the supera stent and the other part was inside the introducer sheath.The device was removed with the introducer sheath to remove half of the balloon, and the other half that was inside the supera stent was removed via cut-down procedure.The supera stent was not damaged by the armada 35 bdc; however, the stent was also removed to remove the remaining half of the armada balloon.The distal markers that separated as well were also removed via cut-down.The lesion was noted to be patent; therefore, no further treatment was done.Angiography was performed which confirmed that the patient was stable.No additional information was provided.

• 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: 7938420
• MDR Text Key: 122855760
• Report Number: 2024168-2018-07700
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/05/2018

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 Catalogue Number: UNK SUPERA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2018
• Initial Date FDA Received: 10/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: BALLOON CATHETER: ARMADA
• Patient Outcome(s): Required Intervention