MAUDE Adverse Event Report: AV-TEMECULA-CT ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

Catalog Number 1011921-060

Device Problems Premature Activation (1484); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned for analysis.The investigation was unable to determine a cause for the reported difficulties.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.Based on the information reviewed, 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 resistance with anatomy was met when advancing the 6.0 x 60 absolute pro stent delivery system (sds) to the superficial femoral artery (sfa).Before the sds reached the intended deployment area, the stent began to unsheathe and the stent prematurely deployed with the thumbwheel locked.The absolute pro stent was deployed at least 1 to 2 cm above the intended landing zone in the sfa.Approximately two thirds of the target lesion was treated with the absolute pro stent.A supera stent was used to fully cover the lesion.No additional information was provided.

• Brand Name: ABSOLUTE PRO .035 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: 6055907
• MDR Text Key: 58527112
• Report Number: 2024168-2016-07295
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08717648115097
• UDI-Public: (01)08717648115097(17)190731(10)6080561
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K072708
• 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
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 1011921-060
• Device Lot Number: 6080561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2016
• 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