MAUDE Adverse Event Report: AV-TEMECULA-CT SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number	S-65-150-120-P6
Medical Device Problem Codes	Positioning Failure (1158); Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: visual and functional inspection was performed on the returned device.The reported deployment issue was confirmed due to dried blood.The investigation was unable to determine a cause for the initial reported difficulty.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.T here is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a non-tortuous, concentric, 60% stenosed lesion in the distal femoral artery.A contra-lateral puncture was made and a 6fr introducer was placed.The.018 inch guide wire was advanced crossing the lesion in place of popliteal.An armada 18 balloon was advanced to perform pre-dilatation of the lesion.The length and diameter of the stent was evaluated.A supera 6.5 x 150 mm stent was chosen.It was purged and the device was advanced to the segment to be treated.The latch was removed from the system to initiate the release, there was a resistance in the thumbslide and by means of fluoroscopy the stent driver shows that it advances as the thumbslide is moved but it did not initiate the stent release.Another device was used for the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Device analysis revealed the stent implant was returned partially deployed.
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Common Device Name: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7754759
• Report Number: 2024168-2018-06055
• Device Sequence Number: 1939110
• Product Code: NIP
• UDI-Device Identifier: 08975370026399
• UDI-Public: 08975370026399
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: S-65-150-120-P6
• Device Lot Number: 6050661
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/17/2017
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1