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

Catalog Number S-60-150-120-P6

Device Problems Detachment Of Device Component (1104); Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported that the thumb slide did not feel right during deployment of the supera stent in the superficial femoral artery.The tip of the stent delivery system (sds) was noted to have separated during removal of the sds from the anatomy.The tip remained on the guide wire and was pulled into the 7 french sheath.The tip was removed on the wire with the sheath.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Subsequent to the initial 30-day medical device report, additional information was received that this event is a duplicate of mfr# 2024168-2017-01642.See mfr# 2024168-2017-01642 for complete details.

Event Description

Subsequent to the initial 30-day medical device report, additional information was received that this event is a duplicate of mfr# 2024168-2017-01642.See mfr# 2024168-2017-01642 for complete details.

• 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: 6372463
• MDR Text Key: 69159531
• Report Number: 2024168-2017-01706
• 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: 03/30/2017

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 Catalogue Number: S-60-150-120-P6
• Device Lot Number: 5102761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2017
• Initial Date FDA Received: 03/02/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: SHEATH: 7F