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

Catalog Number 1012532-60

Device Problem Kinked (1339)

Patient Problem Perforation (2001)

Event Date 03/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical devices: dilatation catheter: ultraverse 6x100mm, 4x40mm; armada 35 10 x40mm; guide wire: unspecified 40g gw, jupitar max sheath: 4 fr; 6 fr.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 mildly tortuous, heavily calcified, eccentric, 100% stenosed, de novo common(cia) and external iliac (eia) arteries, a 10 x 60 mm absolute pro stent may have kinked, but was deployed without issue in the eia.Following deployment, a 10 x 40 mm armada 35 balloon was used for post-dilatation.During post dilatation of the 10 x 60 mm absolute pro stent, a perforation was noted.The balloon was inflated for 30 minutes, but the perforation did not resolve.The patient was transferred to another hospital.A non-abbott stent was implanted, resolving the perforation.The patient was discharged sometime later.No additional information was provided.

Manufacturer Narrative

(b)(4).There was no reported device malfunction and the product was not returned as it remains implanted.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 incidents reported from this lot.Perforation is listed in the absolute pro instruction for use (ifu) as a known patient effect associated with the use of a stent in peripheral arteries.It is likely that the kink and perforation occurred due to anatomical conditions.Based on the case information and related record review, the reported difficulties appear to be due to case circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 7453244
• MDR Text Key: 106246229
• Report Number: 2024168-2018-02995
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 1012532-60
• Device Lot Number: 6061361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 69 YR