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

Catalog Number 1012009-120

Device Problems Break (1069); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant product(s): dilatation catheter: 5.0x120mm armada 35.Guide wire: 0.035 terumo.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 during a procedure of the moderately tortuous, mildly calcified, 80% stenosed, de novo, mid right femoral artery, 10 cm lesion with normal outflow, a 6.0 x 120 absolute pro stent was implanted without issue.Post dilatation with a 5.0 x 120 mm amada 35 balloon could not be performed as the balloon could not be advanced properly into the stent.The balloon was removed and angiography performed, noting that the stent was fractured.The wire was changed out and post-dilatation of the stent was performed with an unspecified balloon first and then with the same 5.0 x 120 mm armada 35 balloon, without issue.The final angiographic result was reported as nice.No additional intervention was performed.There was no additional information provided.

Manufacturer Narrative

(b)(4).The delivery system was not returned for analysis.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the complaint handling database revealed no other similar incidents reported from this lot.A cine was received and reviewed by an abbott vascular clinical specialist, who noted that the stent struts were misaligned with a discontinuous pattern.The investigation was unable to determine a cause for the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• Brand Name: ABSOLUTE PRO LL 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: 7152839
• MDR Text Key: 96003420
• Report Number: 2024168-2017-10149
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 1012009-120
• Device Lot Number: 6090761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• 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