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

Catalog Number	S-65-080-120-P6
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2017
Type of Reportable Event	Serious Injury
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 evaluation.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.The investigation was unable to determine a conclusive cause for the reported difficulties.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the distal left superficial femoral artery.After pre-dilatation with a 7x40mm balloon the 6.5x80mm supera stent delivery system (sds) was advanced and the stent deployed in the lesion [aneurysm]; however, during retraction of the sds the tip/nosecone caught on a stent strut and the delivery system could not be removed.Access was gained from the left groin antegrade and a 7x40 mm balloon was inflated distally to anchor the stent, which allowed the sds to be retracted from the stent without issue.The stent was successfully fully deployed at the target aneurysm site.The procedure continued on with coiling of the artery to complete treatment of the aneurysm.The procedure was noted as being prolonged; however, this was not clinically significant and the final result was good.No adverse patient effects were reported.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: 6309344
• Report Number: 2024168-2017-01010
• Device Sequence Number: 1200407
• Product Code: NIP
• UDI-Device Identifier: 08717648213021
• UDI-Public: (01)08717648213021(17)180228(10)6032962
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: S-65-080-120-P6
• Device Lot Number: 6032962
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2017
• Initial Report FDA Received Date: 02/07/2017
• 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: SHEATH: 7 FR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR