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

Catalog Number S-05-120-120-G3

Device Problems Detachment Of Device Component (1104); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2014

Event Type  Injury  

Event Description

It was reported that some resistance was met while advancing the supera stent delivery system (sds) to the heavily calcified, mildly tortuous target lesion in the predilated, superficial femoral artery (sfa).The supera stent was implanted in the sfa without incident.After the sds was removed from the anatomy, it was noted that the sds did not have a tip.On fluoroscopy, it was confirmed that the tip of the sds remained on the guidewire.The detached tip was successfully retrieved with a balloon dilatation catheter.There was no adverse patient sequela and no clinically significant delay in procedure.The patient was discharged in stable condition.There was no additional information provided.

Manufacturer Narrative

(b)(4).The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned and the reported tip detachment was confirmed.A review of the device history record revealed no non-conformances that would have contributed to the reported event.Additionally, a query of the electronic complaint handling database revealed no other similar incidents reported from this lot.Based on the reviewed information, no product deficiency was identified.

• Brand Name: SUPERA PERIPHERAL 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 462
• Manufacturer (Section G): WEBSTER, TX USA REG#3005325609; abbott vascular; 26531 ynez rd.; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3803547
• MDR Text Key: 4381026
• Report Number: 2024168-2014-02995
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Catalogue Number: S-05-120-120-G3
• Device Lot Number: 02030038
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/29/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• 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 Outcome(s): Required Intervention