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

Catalog Number	S-65-100-120-P6
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2016
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.The device was not returned for analysis.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 identified no other incidents 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.The investigation was unable to determine a conclusive cause for the reported partial stent deployment and the stent elongation appears to be related to the circumstances of the procedure.
Event or Problem Description
It was reported the procedure was to treat a lesion in the left common femoral artery.The vessel diameter was 6.5 mm.A 6fr introducer sheath was used for access.Atherectomy was used.Pre-dilatation was performed with an unspecified 6.0mm non-abbott balloon dilatation catheter.The 6.5 x 100 mm supera self-expanding stent (sess) was advanced in the patient anatomy, however during deployment the stent elongated; partially deployed inside the patient and partially inside the sheath.The sess was removed along with the partially expanded stent, without issue.There was no resistance during deployment or during removal.The procedure was aborted.There was no adverse patient effect and no clinically significant delay during the procedure.No additional information was provided.

• 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: 6095632
• Report Number: 2024168-2016-07886
• Device Sequence Number: 680923
• Product Code: NIP
• UDI-Device Identifier: 08975370026375
• UDI-Public: (01)08975370026375(17)180208(10)6032361
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/11/2016

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: 02/28/2018
• Device Catalogue Number: S-65-100-120-P6
• Device Lot Number: 6032361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2016
• Initial Report FDA Received Date: 11/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTRODUCER SHEATH: 6FR
• Patient Weight: 52