MAUDE Adverse Event Report: AV-TEMECULA-CT ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number 1012534-100

Device Problems Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.Based on the reported information, the damage was due to interaction with the non-abbott scoring balloon catheter.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the electronic complaint handling database revealed no other similar incidents reported from this lot.The investigation determined that the reported difficulties and additional treatment was due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a lesion in the non-tortuous, mildly calcified, 85 to 90% stenosed, distal superficial femoral artery (sfa).A 6.0 x 100 mm absolute pro stent was successfully deployed in the target lesion with no issues noted.A non-abbott scoring balloon catheter (sbc) was advanced with the intention of inflating the balloon proximal to the previously implanted absolute pro stent.The sbc was inadvertently advanced through the absolute pro stent until it was distal to the stent.As the sbc was being pulled back through the absolute pro stent, the balloon caught on the distal edge of the stent.Force was used to pull the sbc back causing the absolute pro stent to be pulled back into itself creating what appears as a nest.Using excessive force, the sbc was removed from the anatomy and a 30-40 mm section of the balloon was observed to have separated from the sbc and remained in the anatomy.An armada 35 percutaneous transluminal angioplasty (pta) catheter was advanced to the absolute pro stent and inflated to create a channel through the stent.Then a non-abbott covered stent was implanted inside the absolute pro stent with the distal end of the covered stent extending past the distal end of the absolute pro stent.Another armada 35 pta catheter was used to post-dilate the covered stent.No additional information was provided.

• Brand Name: ABSOLUTE PRO VASCULAR 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: 7139747
• MDR Text Key: 95543211
• Report Number: 2024168-2017-10062
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648176012
• UDI-Public: 08717648176012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110028
• 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
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 1012534-100
• Device Lot Number: 7071061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2017
• 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: OTHER: ANGIOSCULPT SCORING BALLOON CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 74