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

Catalog Number 1012534-80

Device Problems Break (1069); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for evaluation and the reported pulled out strain relief tubing was confirmed.Based on visual analysis of the returned device, there is no indication of a product quality issue with respect to manufacture, design, or labeling.The investigation concluded that the pulled out strain relief tubing and shaft damage appear to be due to operational context.A review of the lot history record revealed no non-conformances.A query of the electronic complaint handling database revealed no other similar incidents reported from this lot.Based on the information reviewed, indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that during a procedure to treat a lesion in the right superficial femoral artery (sfa), a supera stent was implanted in the distal sfa.An attempt was then made to advance a 6.0x80 mm absolute pro vascular self-expanding stent system (sess) over the unspecified guide wire.However, prior to entering the sheath the plastic portion (strain relief tubing) with the detachable outer jacket by the handle detached and could not be re-attached.The stent system was simply removed from the guide wire and replaced with a new same size absolute pro vascular sess was used to successfully treat the target lesion.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.Subsequent returned device analysis revealed that there was a radial tear in the outer member, 2mm distal to the distal end of the handle.

• 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: 4996347
• MDR Text Key: 24132133
• Report Number: 2024168-2015-04554
• Device Sequence Number: 1
• Product Code: NIO
• 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
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: 1012534-80
• Device Lot Number: 4012361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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 Age: 70 YR